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3 weeks ago

Production Document Support Specialist

Bachem - Vista, CA 92081

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com. A brief overview The Production Document Support Specialist will support the production department in authoring, editing, reviewing and maintaining production documents to verify accuracy before on-time final presentation. The specialist will ensure good documentation practice (GDP) implementation and build efficient collaboration between production department and other supporting departments such as operations, logistics, QC, and QA. What you will do Perform and coordinate BPR (batch record) technical reviews. Ensure that written procedures (SOP, BPR) and cGMP guidelines are followed. Exercise independent judgment regarding cGMP document entry evaluation. Coordinate real time batch record review/corrections across multiple functions, i.e., Production, QA Attend and scribe daily huddles; coordinate collaboration between Production department and other departments such as Operations, Logistics, QC, and QA; perform other tasks supporting Production as assigned Perform controlled print tasks for time-sensitive production operations Comply with SOP’s, BPR’s and cGMP in all aspects of the work performed. Participate in internal audits, support GMP readiness activities, audits and inspections Implement improvements in quality systems and SOPs. Manage operational excellence tasks. Process assigned tasks and reviews within tight timelines Qualifications Bachelor's degree in science, engineering, or related discipline or Associate degree in science, engineering, or related discipline with 2+ years’ experience in cGMP setting Experience managing documents in a cGMP environment, particularly in API manufacturing (preferred) Knowledge of cGMP and FDA regulations (preferred) Experience with Master Control, SAP, Excel, Word, PowerPoint (preferred) Industry experience with peptide manufacturing (preferred) Working experience with mandatory safety, health and compliance regulations as specified by federal, state, and local agencies (preferred) Ability to adhere to manufacturing schedules and timelines for document support Capable of working methodically and efficiently, while adhering to rules and regulations Reviewing, entering or recording information in written or electronic form Strong understanding of cGMPs, and able to comply with SOPs, BPRs and cGMP in all aspects of the work performed. Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of compositions, and grammar. Well versed in Good Documentation Practices. Detail oriented with the ability to independently troubleshoot and resolve problems Communicate effectively, and possess ability to function well in a team environment Possess a GMP mindset with a high degree of self-discipline in tasks Ability to perform under pressure and adhere to guidelines and timelines Excellent communication and interpersonal skills. Ability to collaborate in a proactive and solution-focused manner, including keeping management aware of potential issues. Ability to work in ISO7 and ISO8 controlled environments Base Hourly Range: Specialist I: $25.97 - $35.72 Specialist II: $37.00 - $50.87 Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training. Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem. Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status. Please note: unsolicited resumes from recruitment agencies will not be considered. Nearest Major Market: San Diego

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3 weeks ago

Assembler

Select Source International - San Diego, CA 92121

Roles & Responsibilities This position has responsibility for: •Observes all safety regulations including personal protective equipment. •Assemble components to a final configured product utilizing process instructions, engineering documentation (assembly drawings, wire lists, etc.), specialized tooling and fixtures, measuring equipment, and hand tools. •Reads and interprets assembly drawings, parts lists, operations sheets and visual aids. Make recommendations for changes to improve build processes. •Perform any rework from test failures in accordance with standard repair procedures. May also incorporate ECN's into completed boards. •Prep and insert electronic components onto circuit boards, hand solder components onto circuit boards, touch up and rework circuit boards. •Verify quality of product at the required intervals and verify accuracy of all work. •May provide training and support to lower-level assemblers as required. •Ability to operate material handling equipment, read and interpret engineering documentation, layout, and process worksheets, set-up and operate assigned machines and equipment. •Meets established standards for productivity and quality. •Follow the lead’s instruction on building units. Competency Requirements In order to perform the job successfully, an individual should demonstrate the following competencies: •Attention to Detail •Manual Dexterity •Teamwork •Interpersonal Skills Minimum Qualifications (Experience and Skills) •Typically requires a minimum of 1 - 3 years of related experience. Preferably electrical and/or electro-mechanical assembly. •Must possess good to excellent assembly blueprint reading experience/skills. •Must be able to use hand tools (i.e. torque wrench, drills and inspection tools). •Ability to properly read a variety of measuring devices including rulers, tape measures, and scales. •Must be able to communicate effectively with others. •Basic computer skills. •Performs other duties as assigned. Education Requirements •High school diploma or equivalent Preferred Requirements •IPC-610 and J-STD 001 certification Job Type: Contract Pay: $18.00 - $20.00 per hour Expected hours: 40 per week Work Location: In person

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3 weeks ago

Manufacturing Equipment Engineer

EPC Power Corp. - Poway, CA 92064

Description: We are seeking a versatile Manufacturing Equipment Engineer to support our production operations by operating and maintaining our prototype machine shop and acting as the first line of support when our automated production lines require troubleshooting. This role combines hands-on machining and fabrication with basic maintenance and repair of production equipment. Key Responsibilities: · Operate and maintain a variety of shop equipment, including: · CNC Mill, Drill Press, Miter Saw, Abrasive Saw, Sheet Metal Brake, Disc Sander, Arbor & Hydraulic Press, Din Rail Cutter, Laser Cutter, Bench Grinder, 3D Printer. · Act as the first point of contact (POC) when automated production lines experience downtime — perform basic troubleshooting and minor repairs for mechanical, electrical, pneumatic, hydraulic, or control-related issues. · Examples of automated equipment are conformal coating machine, oven, press-fit machine, glue dispensing machine, robotic gantry, bus-bar bender. · Fabricate, modify, or repair parts, tools, and fixtures to support R&D, production, or prototyping. · Carry out and log routine/planned maintenance on shop and manufacturing tools/equipment; maintain a clean, organized, and safe workspace. · Coordinate with external vendors when advanced repairs are required. · Schedule, track, and coordinate calibration of measurement tools, gauges, and equipment as required to meet production and quality standards. · Work with engineering and production to enhance tooling, fixtures, and processes to boost reliability and up-time. · Order and maintain inventory of necessary tooling, consumables, and maintenance parts. · Document work performed, update records, and communicate status and issues to the Production Manager and Engineering as needed. planned and routine maintenance logs Requirements: · Minimum: Associate’s degree or vocational training in machining, mechatronics, or industrial maintenance; bachelor’s degree preferred. · Experience supporting automated production equipment in a manufacturing environment. · Familiarity with ERP systems for tracking work orders and spare parts. Pay: $80-$100K

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3 weeks ago

Associate Technician Product Testing

TaylorMade Golf - Carlsbad, CA 92008

This position is responsible for performing, documenting, and reporting the results of various tests and measurements within the laboratory on golf-related products and materials. The role provides support for Woods Product Development and Advanced Design, ensuring accurate and timely test data to engineers and management. Essential Functions and Key Responsibilities: In conjunction with the responsible engineer, conduct development tests in an assigned area of responsibility during development of product, materials, equipment, and processes, using engineering drawings, sketches, procedures, written and verbal instructions. Apply knowledge in such areas as: precision measuring equipment, tooling, plastics, test equipment, and hand tool usage to carry out responsibilities. Set up equipment and tools to conduct test and inspections; conduct tests and inspections; compile and plot data, submit results to designated personnel. Review measurement data and troubleshoot suspect results that may be due to measurement. Assemble and disassemble clubs and/or equipment. Perform routine maintenance on tools and equipment. Enter data in PC and produce simple reports. Carry out responsibilities in accordance with established safety procedures and practices. Participate regularly in process improvement within areas of responsibility. Performs other related duties and assignments as required. Knowledge and Skills Requirements: Strong attention to detail and ability to work accurately with numerous details. Proven ability to work in a team-oriented, collaborative environment. Proficient in Microsoft Suite (Word, Excel, Outlook, PowerPoint). Strong English written and verbal communication skills and ability to interact with all levels. Demonstrated ability to use arithmetic (decimals, percentages, fractions) to perform calculations, set-ups, inspections, tests and report results. Able to read engineering drawings and specifications. Ability in the use of precision measuring instruments and hand tools. Able to safely operate, maintain equipment and perform various set-ups and tests. Demonstrated organizational skills and ability to work accurately with numerous details Able to effectively interface with others at all levels of the organization. Education, Work Experience, and Professional Certifications: High school diploma Minimum 3 months of experience using precision measuring tools Work Environment / Physical Requirements: Must be able to stand for long periods of time. Exposure to laboratory environment with equipment dust and noise. Demonstrated ability to work with hands. Physically able to lift 25 lbs, bend, stoop, reach and perform non-routine tasks as require. Able to work various shifts and/or overtime as required. Able to work efficiently and accurately in an atmosphere of frequent interruption. TaylorMade is a performance driven organization and our total rewards approach to compensation is designed to support this. We consider many factors in determining base compensation, including position scope, job related knowledge, education, skills, experience, and work location. The expected annual base pay range for this position is $21 - $23 per hour. Additional benefits, such as health & wellness, performance bonuses, product discounts, holidays, paid time off, etc. may also be offered in accordance with our plans. #LI-Onsite #LI-AP1 TaylorMade Golf Company is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to race, religious creed, color, national origin or ancestry, physical or mental disability, medical condition, genetic information, marital status, sex, pregnancy, gender, gender identity, gender expression, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law, ordinance, or regulation.

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3 weeks ago

Brewer 1

Karl Strauss Brewing Company - San Diego, CA 92109

The Brewer 1 performs all aspects of beer production, from beginning to end at the Main Brewery. This includes brewing, cellar operations, filtration, cleaning and sanitation, maintenance of plant equipment, general upkeep of the home office facilities and other associated duties. Opportunity to brew, under supervision, at one of our Brewery Restaurants for the purposes of training and advancement. Essential Functions & Duties Efficiently operates all brewing equipment at the Main Brewery including the brew house, filters, kegging machine, cleaning equipment, milling equipment, and all other support equipment in the brewery. Monitors fermentation; cleaning and sanitizing tanks, and yeast management. Responsible for the successful operation of the brewing process at the Home Office Brewery. Cleans and general up keep of the entire brewery at all times. The assignment of any of the following duties; Multiple shift brewer: The brewer will arrive at a pre-determined time dependent upon the shift they are assigned based on the production schedule. We are Brewing 24 hrs a day/7 days a week. There are multiple shifts associated with the all brewing positions and any brewer can be assigned to any shift. All brewers will prepare the brewery for the day’s production schedule. The brewer may also mill-in the subsequent brew and then transfer it over to the brew house. The brewer finishes his/her brew, then cleans the workstation, then completes all associated paperwork and/or data entry. Filter Operator: The filter operator will arrive at a pre-determined time. The filter operator cleans and sanitizes the tank that he/she will filter into, prepares and operates the filters during the production process, starts the carbonation process once the beer moves to the bright tank, thoroughly cleans the filtration workstation when finished, and completes the associated paperwork and/or data entry. Cellarperson: The cellarperson cleans and sanitizes any fermenters required. As time permits he/she cleans any other areas of the brewery as assigned. The cellarperson also performs the yeast-pitching/management for the production schedule. Know and love beer. High school diploma or equivalent. At minimum, two years experience working in a brewery as an assistant brewer or brewer. Able to work basic computer programs such as MS Outlook, Word and Excel. Mechanical aptitude required and experience working with small tools. Must have an excellent attitude and conform to all of the company policies. Must have a clean driving record. Physical Demands: Very heavy work - Employee typically shares workstations with others in similar positions. Time spent conducting sedentary work is less than 10%. Requires walking, standing, and/or driving for more than 90% of the workday. Lifting objects in excess of 100 pounds with frequent lifting and/or carrying of objects weighing 50 pounds or more. *Karl Strauss participates in E-Verify. Click to view: Notice of E-Verify Participation or Right to Work Notice

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3 weeks ago

New Product Introduction Engineer

Innova Engineered Plastics - Poway, CA 92064

An NPI (New Product Introduction) engineer is a professional responsible for managing and overseeing the process of introducing new products into manufacturing. This role typically bridges the gap between product design and mass production. The NPI engineer's responsibilities include ensuring that the product design is manufacturable, testing production processes, troubleshooting issues, and coordinating with various teams like design, sales, engineering, quality, and manufacturing to ensure smooth product launches. *Key Responsibilities* · Work closely with the design team to ensure that new products are designed for manufacturability, cost-effectiveness, and efficiency. · Collaborate with various teams such as design, operations, quality assurance, and logistics to ensure the product is ready for production. · Evaluate product technical requirements and help define technical specifications. · Help create prototypes for the new product, identify potential design or production issues, and test different manufacturing methods. · Develop and optimize manufacturing processes, ensuring they meet quality standards and can be scaled for production. · Coordinate testing of the product and production processes to verify that the product performs as intended. · Oversee the entire product lifecycle, from development to launch, ensuring smooth transitions between each phase. · Ensure the product is built to specifications and that it meets quality standards. · Address any issues that arise during the transition from prototype to mass production, including supply chain or assembly challenges. · Create and maintain documentation of processes, designs, and testing results, and provide regular updates to senior management. · Independently work through complex problems with some input from Senior colleagues. · Document technical specifications, product features, and updates. · Has experience in multiple development phases, including those guided by Design Controls requirements. Demonstrates familiarity and compliance with Quality SOPs. · Demonstrates a strong understanding of ISO 13485, sufficient to participate in an audit and/or guide coworkers. · Demonstrates a functional technical and clinical understanding of products being actively worked on. Demonstrates a developing breadth of technical process expertise. · Follows safety requirements. *Education & Skills:* * Bachelor’s degree in engineering (Mechanical, Manufacturing Preferred) * Five years or more of related experience required in a manufacturing environment. * 5-10 years' experience in the medical device design/development field. * Proficient in Microsoft Office: MS Teams, Excel, PowerPoint, Outlook. * Familiarity with ISO 13485 * Familiarity with Plastic Materials and Processes * Foundational SolidWorks skills. *Work Environment:* Office setting Manufacturing floor environments Controlled temperature environments *Expected Hours of Work* This is a Full-Time Salary position required to work Monday through Friday, with occasional weekends. *Travel:* Up to 10% Job Types: Full-time, Permanent Pay: $110,000.00 - $130,000.00 per year Benefits: * 401(k) * Dental insurance * Employee assistance program * Health insurance * Paid time off * Vision insurance Work Location: In person

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3 weeks ago

Quality Analyst

General Atomics - San Diego, CA

General Atomics Electromagnetic Systems (GA-EMS) is a supplier of advanced electromagnetic systems, related power equipment and other high technology products for a variety of government and commercial applications. These include products such as the design and fabrication of linear motors, superconducting and conventional rotating motors, power inverters, high-energy capacitors, radiation monitoring systems, high-voltage direct current power distribution systems, and numerous other products. Under close supervision, this position is responsible for developing, analyzing and reporting on quality plans, programs and discrepancies related to assembly, process, mechanical, electrical and electro-mechanical systems. Investigates problems and develops corrective action plans for quality system discrepancies. Ensures that quality performance and records conform to established company and regulatory standards. Interfaces with manufacturing, engineering, customers, vendors and subcontractor representatives to ensure requirements are met. May support calibration program, safety program, records center, and other Quality department administrative activities. DUTIES AND RESPONSIBILITIES: Reviews quality records and data on various elements of the company's Quality Management System to ensure compliance, determine trends, and analyze root cause (ex: travelers, nonconformance reports, corrective actions, inspection results, configuration logs, training records). Coordinates with responsible personnel and supervisors to develop or obtain corrective action plans. Prepares summary reports, charts, and statistical analysis as required. Plans, coordinates, and leads internal audits and surveillance activities of the company's Quality Management System, including interviews, observations, and review of manufacturing, inspection, and test operations and records on shop floor. Creates summary reports and reviews results with management. Conducts opening and closing meetings with responsible management for areas being audited. Supports Quality department administration, develops databases, prepares reports. May supervise records center operations, train and oversee department assistants to review quality records for incomplete operations and errors. Provides training and coordinates with responsible personnel and supervisors to get records corrected, prevent recurrence, and improve processes. Responsible for observing all laws, regulations and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to work in a safe manner in accordance with established operating procedures and practices. Other duties as assigned or required. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. Job Qualifications Typically requires a Bachelors degree in Manufacturing Technology, Mathematics or related field. May substitute additional experience as a quality analyst in lieu of education. Requires a general understanding of quality procedures and system requirements in a manufacturing environment as well as general knowledge of quality concepts and principles including the ability to read and understand engineering drawings and specifications; the ability to identify and interpret data; the ability to prepare detailed statistical reports and documents; interpersonal, verbal and written communication skills to explain general information effectively with all levels of employees; organization skills to maintain flow of work within the unit; the ability to establish priorities; and general knowledge of computer operations and applications and word processing and spreadsheets. Must be customer focused and able to work on a self-initiated basis or in a team environment and able to work extended hours and travel as required. Job Category Quality Experience Level Entry-Level (0-2 years) Workstyle Onsite Full-Time/Part-Time Full-Time Salary Pay Range Low 51,650 Pay Range High 87,290 Travel Percentage Required 0% - 25% Relocation Assistance Provided? No US Citizenship Required? Yes Clearance Required? No

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3 weeks ago

Manager, Quality Engineering Operations

SCIEX - Carlsbad, CA 92008

For over 50 years, SCIEX has been developing groundbreaking technologies and solutions in mass spectrometry and capillary electrophoresis. Our products enable our customers to quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster and keep food healthier and safer. At SCIEX, you’ll find a rewarding role that amplifies your impact on the world and helps you realize life’s potential. SCIEX is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health. Learn about the Danaher Business System which makes everything possible. Want to lead a hands-on Quality Assurance team that drives operational excellence and technical problem-solving in a fast-paced manufacturing environment? The Manager, Quality Engineering Operations is responsible for responsible for leading a team of QA Engineers and Technicians to ensure product and process quality across manufacturing operations and maintaining a full QMS compliant to the site specific ISO 9001 certificate including managing audits by regulatory authorities and customers. This role focuses on technical troubleshooting, process validation, equipment qualification, and supplier quality engagement. You’ll have opportunities to lead continuous improvement projects, collaborate with cross-functional teams, and make a direct impact on operational performance. This position is part of the Quality Assurance and Regulatory Affairs department and will be in Carlsbad. Our team’s vision is to deliver world-class quality through proactive risk management, technical excellence, and operational efficiency. In this role, you will have the opportunity to: Implement Daily Management practices to monitor KPIs and drive rapid issue resolution. Lead process validation, test method validation, and equipment qualification (IQ/OQ/PQ). Oversee calibration and maintenance programs for equipment reliability. Drive root cause analysis and corrective actions for NCRs, CAPAs, and complaints. Collaborate with Operations and Engineering to improve process capability and reduce variability. Lead continuous improvement initiatives to enhance product quality and operational efficiency. Lead and develop a team of technicians and engineers, including the ability to lead through influence across cross-functional teams. The essential requirements of the job include: Bachelor’s degree in Engineering or related technical discipline; advanced degree preferred. Minimum 5 years experience in Quality Assurance or Quality Engineering within a regulated manufacturing environment, including leadership experience. Strong technical knowledge of manufacturing processes, equipment, and validation methodologies. Proven ability to lead hands-on troubleshooting and problem-solving in production environments. Familiarity with ISO 9001 and QSR requirements; experience with audits and compliance. Proficiency in data analysis, SPC, and risk-based decision-making. Ability to work cross-functionally with Operations, Engineering, and Supply Chain teams. It would be a plus if you also possess previous experience in: Leading cross-functional engineering projects focused on process improvement and equipment performance. Managing or supporting site relocation or major facility transitions, ensuring continuity of quality and operations. Chemical or reagent design and manufacturing processes, bringing practical knowledge to QA oversight. SCIEX, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com. The annual salary range for this role is $102,000 – 178,000 USD. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. #LI-LCS Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com.

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3 weeks ago

Senior Quality Engineer

SCIEX - Carlsbad, CA 92008

For over 50 years, SCIEX has been developing groundbreaking technologies and solutions in mass spectrometry and capillary electrophoresis. Our products enable our customers to quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster and keep food healthier and safer. At SCIEX, you’ll find a rewarding role that amplifies your impact on the world and helps you realize life’s potential. SCIEX is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health. Learn about the Danaher Business System which makes everything possible. Do you want to make history in a company that advances human wellness through the power of precise science? To be part of dynamic collaborations that drive results that enable SCIEX to deliver growth and innovative, reliable solutions for customers worldwide? The Senior Quality Engineer is a technical Quality subject matter expert that supports process and product lifecycle through management of risk to protect customer satisfaction and business value. This role will empower Carlsbad plant in becoming the “functionally competent” center of excellence for consumables for SCIEX, and instrument company. This position is part of the Quality Assurance and Regulatory Affairs department and will be in Carlsbad. Our team’s vision is to deliver world-class quality through proactive risk management, technical excellence, and operational efficiency. In this role, you will have the opportunity to: Lead quality engineering activities for new product development (NPD) and design transfer, ensuring readiness for commercial launch while operating with independence and accountability. Develop and execute Quality Plans in collaboration with cross-functional teams, applying statistical methods, risk analysis, and design of experiments to drive robust product and process outcomes. Create, review, and approve design validation and verification protocols, ensuring traceability to technical and regulatory requirements and applying critical thinking to resolve complex challenges. Provide technical oversight for product changes and process validations (IQ/OQ/PQ), including risk assessments, compliance verification, and coaching teams on rigorous decision-making. Drive continuous improvement initiatives to enhance product quality and manufacturing processes, fostering strong team engagement and collaboration. The essential requirements of the job include: Bachelor’s degree with 5+ years of relevant experience, or Master’s degree with 3+ years in Quality Engineering or a related field. Familiarity with the operation and functionality of Mass Spectrometry and Capillary Electrophoresis instruments. Proven ability to apply statistics, design of experiments (DOE), and risk analysis in developing Quality Plans and reviewing validation/verification protocols for compliance and technical soundness. Skilled in overseeing product change processes—evaluating rationale, conducting cross-functional risk assessments, and ensuring compliance for both permanent and temporary changes. Demonstrated ability to work independently, exercise sound judgment, and apply critical thinking while maintaining strong collaboration with cross-functional teams. It would be a plus if you also possess previous experience in: Direct QC Testing: Hands-on experience performing quality control testing on Mass Spectrometry and Capillary Electrophoresis instruments for both production and investigational/manufacturing transfer protocols. Working knowledge of ISO 13485, ISO 9001, and FDA 21 CFR Part 820, as applied to manufacturing. Familiarity with quality systems and continuous improvement methodologies, with a strong focus on team engagement and driving collaborative solutions. SCIEX, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com. The annual salary range OR the hourly range for this role is 102,000 – 178,000 USD annual. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. #LI-LCS Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com.

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3 weeks ago

Manufacturing Technician I

Catalent Pharma Solutions - San Diego, CA 92121

Manufacturing Technician I (1st Shift) Position Summary: Work Schedule: Monday-Friday from 7:30am-4pm 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent’s San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution. Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client’s most challenging compounds. The Manufacturing Technician I will be responsible for conducting Good Manufacturing Practices (cGMP) manufacturing of solid oral and liquid oral pharmaceutical dosage forms for Phase I and Phase II clinical trials. Daily responsibilities will include production equipment set up, weighing of materials, sieve and blending activities, spray drying, milling, granulation, mixing, roller compaction, submitting samples, encapsulation, tableting, coating and packaging. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients. The Role: Prepare materials, equipment and manufacturing suites for production Conduct GMP manufacturing of solid oral and liquid oral dosage forms Packaging and labeling of manufactured products Pre/postproduction cleaning of equipment, supplies and manufacturing area Follow Standard Operating Procedures (SOPs) and production batch records Responsible for accurate documentation in production batch records May also assist engineering with equipment validations, preventative maintenance, and cleaning verifications Other duties as assigned The Candidate: High School Diploma or GED equivalent is required One (1) year of experience is required in GMP pharmaceutical or medical device manufacturing Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently Pay: The anticipated salary range for this role in California is $40,000 to $46,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. Several Employee Resource Groups focusing on Diversity and Inclusion. Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. 152 hours of PTO + 10 paid holidays. Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. Tuition Reimbursement – Let us help you finish your degree or earn a new one! WellHub program to promote overall physical wellness. Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

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3 weeks ago

Manufacturing Maintenance Manager

CAPTEK Softgel International - Vista, CA 92081

Become part of a team that champions wellness worldwide. CAPTEK® Softgel International is a global leader in the development and production of high-quality nutraceutical supplements. As a contract manufacturer organization (CMO), we collaborate with innovators from some of the world’s most successful brands. Summary: This individual will successfully manage all preventative maintenance and repair activities to effectively support plant operations. This individual will also coordinate and direct the design, planning, construction, maintenance, and alteration of equipment, machinery, buildings, and other-facilities by performing the following duties personally or through subordinates. Essential Duties and Responsibilities: • Maintenance: The Maintenance Manager's duty includes the maintenance, cleaning, and sanitation of the manufacturing areas, general building and office areas. The focus for this role will be establishing a robust preventative maintenance program focused on maximizing equipment uptime and extending asset life. The Maintenance manager is required to understarid the basic knowledge of building construction such as wiring, basic plumbing works etc. • Planning, Directing, budgeting and coordinating: Plan, direct, coordinate the activities of a single facility or several small facilities within the organization; required to hire the needed personnel for carrying out the above mentioned activities. • Preparing and maintaining annual budgets of the facility: Prepare budget that is required for usage of the facilities for the smooth running of the organization; required to approve and authorize budgeted expenditures for operating expenses up to authorized levels. Effectively control and maintain the department's spare parts inventory. • Administrative Duties: Oversee a team of employees from several different areas that include maintenance and janitorial personnel, as well as independent contractors. • Ensure all machinery is up to acceptable working standards • Assess current maintenance work processes, to optimize efficiency • Use data analysis to help prepare for and prevent future problems • Create and implement measures to minimize breakdowns and repairs (performing quality checks of all machinery, tools, equipment etc.) • Troubleshoot problem areas and create a clear plan of action for permanently resolving the problem • Oversee repairs and manage quality of work • Train new employees in maintenance work processes and procedures • Create a work environment with safety as a high priority • Perform evaluations of employees to ensure quality of work • Record ancrtrack daily progress/error reports • Maintain vendor relationships and order new materials as needed • Create and adhere to maintenance budgets • Perform evaluations of employees to ensure quality of work • Record and track daily progress/error reports • Maintain vendor relationships and order new materials as needed • Create and adhere to maintenance budgets • Enforce all health and safety rules and regulations according to state/federal laws and company protocol (e.g., Lockout/Tagout, Arc Flash, GMP's and OSHA) Educational Qualification: • Bachelor's Degree in Engineering or related field required. Experience Qualifications: • Requires at least 4 years' experience in a maintenance management or similar role, dietary supplement or food industry preferred. • An equivalent combination of work experience and education will be considered for the above. Required Skills: • Proven experience as maintenance manager or other managerial role • Experience in planning maintenance operations • Solid understanding of technical aspects of plumbing, carpentry, electrical systems etc. • Working knowledge of facilities machines and equipment • Ability to keep track of and report on activity • Excellent communication and interpersonal skills • Outstanding organizational and leadership abilities • Ability to manage complex and varied projects and workloads • Customer and client management skills, • Technical knowledge in construction methods, architectural and engineering drawings, • Project management skills, • Experience with Computerized Maintenance Managements Systems (CMMS) • Travel as required to support business needs Supervisory Responsibilities: • There are supervisory duties; up to 16 direct reports. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly exposed to fumes or airborne particles. The employee is frequently exposed to work near moving mechanical parts and work in high, precarious places. The employee is occasionally exposed to toxic or caustic chemicals; outdoor weather conditions; extreme cold (non-weather); extreme heat (non-weather) and risk of electrical shock. The noise level in the work environment is usually loud. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee must regularly lift and /or move up to 100 pounds, frequently lift and/or moveiiip to 50 pounds and occasionally lift and/or move more than 100 pounds. Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focus. While performing the duties of this Job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear and taste or smell. The employee is occasionally required to sit. CAPTEK is an equal employment opportunity employer. In order to provide equal opportunities to all individuals, employment decisions will be based on merit, qualifications, and abilities, not on any mental or physical disability. We comply with the law regarding reasonable accommodation for disabled employees and applicants. We do not discriminate on the basis of actual or perceived race, color, national origin, ancestry, sex (which includes pregnancy, childbirth, breastfeeding and medical conditions related to pregnancy, childbirth or breastfeeding), reproductive health decisions, gender, gender identity, gender expression, religious creed, disability (mental and physical) including HIV and AIDS, medical condition (cancer and genetic characteristics ), genetic information, age, marital status, sexual orientation, military and veteran status, or any other characteristic protected by federal, state or local law. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment. Thank you for your interest in joining the CAPTEK team. You will be contacted shortly if your application is selected.

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3 weeks ago

Manufacturing Plant Engineer

CAPTEK Softgel International - Vista, CA 92081

Become part of a team that champions wellness worldwide. CAPTEK® Softgel International is a global leader in the development and production of high-quality nutraceutical supplements. As a contract manufacturer organization (CMO), we collaborate with innovators from some of the world’s most successful brands. Summary: The Manufacturing and Continuous Improvement Engineer supports manufacturing through the development and implementation of optimal, cost-effective manufacturing processes and methods in accordance with product specifications and quality standards. In this role you will recommend and implement improvements to manufacturing equipment, production processes, methods and controls. This role is also responsible for working closely with plant operations and maintenance personnel to understand and eliminate losses to improve factory safety, quality and efficiency by utilizing Lean and Continuous Improvement techniques. Essential Duties and Responsibilities: • Performs product/process analysis for cost reduction, quality improvement, and improved efficiency. • Applies Lean Manufacturing and Six-Sigma tools and methodologies in the implementation on continuous improvement initiatives. Implements such tools as: 6S, SMED, VSM, and Kaizen. • Improves manufacturing processes and methods for cost-reduction, quality improvement and efficiency. • Performs research, design and development of manufacturing processes including production flow, assembly methods and production equipment. • Prepares and presents plans for the above and coordinates deployment including training of team members. • Supports new equipment URS development and design reviews as required, provides input in reference to the plant's specifications and good design practices. • Coordinates the manufacturing launch of new/revised products including establishing goals, training team members and evaluating results. • Designs, develops and tests and/or sources and cost-justifies various tools, machinery and equipment for recommended manufacturing methods. • Performs product/process analysis for cost reduction, quality improvement, and improved efficiency. • Responds to any related equipment downtime issues in the plant and establishes any required outside resources to assist in responding to these issues quickly. • Train and develop the plant mechanics to increase their ability to understand and troubleshoot mechanical and process related issues in the plant. • Prepares, reviews and/or approves technical documents to include but not limited to: Technical Reports, SOP's, Cost Quotes, Product and Process Verification/Validation Protocols. • Lead and manage large and small equipment improvement projects in the plant. • Reviews current and new processes; recommends, justifies, demonstrates and implements new manufacturing technologies to enhance our processes. • Maintains documentation on all projects and submits written reports in a timely fashion. • Performs other related duties as assigned. Qualifications: • Strong fundamental knowledge of mechanical and machine design and its application in a manufacturing and production related environment. • Experience using CAD (computer aided design) and CAM (computer aided manufacturing) software. • Critical thinking with exceptional problem solving skills, able to work independently and in team environments. • Proactive, resourceful & highly motivated with Good communication skills and ability to work in a high output environment. • Good communication skills both written and verbal. • Ability to balance multiple projects. • Travel as required to support projects. Education/Experience: • Four year college or university degree or its equivalent in Mechanical Engineering, Manufacturing Engineering or Related Degree. • Requires 2+ years related work experience in a manufacturing environment or an equivalent combination of education and related work experience. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes, or airborne particles and risk of electrical shock. The noise level in the work environment is usually moderate. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical demands require sitting for extended periods of time, walking, bending, reaching, carrying, and occasionally lifting and/or moving objects up to 50 pounds. Specific vision abilities required by this job include Close vision, Peripheral vision, and the ability to adjust focus. While performing the duties of this job, the employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. Thank you for your interest in joining the CAPTEK team. You will be contacted shortly if your application is selected.

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