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General Atomics Electromagnetic Systems (GA-EMS) designs and manufactures first-of-a-kind electromagnetic and electric power generation systems. GA-EMS’ expanding portfolio of specialized products and integrated system solutions support critical fleet, space systems and satellites, missile defense, power and energy, and process and monitoring applications for defense, industrial, and commercial customers worldwide. Under supervision, this position supports the manufacturing production process with focus on the design, development, and implementation of new or revised production processes for the efficient and economical fabrication of parts, components, sub-assemblies, and final assemblies. DUTIES AND RESPONSIBLITIES: Develops, implements, and maintains methods, operation sequence and processes in the manufacture or fabrication of parts, components, sub- assemblies, and final assemblies. Applies technical knowledge to analyze, investigate and resolve manufacturing and engineering related problems. Designs the sequence of production operations, specifying procedures for the fabrication of applicable tools and equipment, and adapting machinery. Collaborates with product design engineering on technical specifications that will best utilize equipment and manufacturing techniques. Investigates, dispositions and justifies product, drawing, and specification non conformances. Estimates manufacturing costs and determines time standards. Ensures that production processes and procedures are in compliance with regulations. Maintains records and reporting systems for coordination of manufacturing operations. Performs supplier audit and oversight as necessary to ensure conforming product being delivered. Communicates technical responses to supply base questions during proposal efforts, manufacturing efforts and post manufacturing efforts. Supports on-site supplier kick off meetings to discuss manufacturing plan, schedule and supplier deliverables. Assist with development, status and needs of the project plan to the Control Account Manager. Maintains the strict confidentiality of sensitive information. Performs other duties as assigned. 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. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. 48937 Job Qualifications: Typically requires a bachelors in engineering or a related technical field . May substitute equivalent experience in lieu of education. The ideal candidate has exposure to welding, fabrication and machining. Degree in mechanical, aerospace manufacturing or industrial engineering is desired. Must have a solid understanding of manufacturing and engineering concepts, principles, and theory with technical experience demonstrating the application of those concepts while ensuring safety and regulatory compliance. Must possess the ability to understand new concepts quickly and apply them accurately throughout an evolving environment and organize work assignments to meet established timetables. Good communication, computer, documentation, presentation, and interpersonal skills are required, as well as the ability to work both independently and as part of a team. Ability to obtain and maintain DoD Secret Clearance is desired. Salary:$56,820 - $96,015Travel Percentage Required 0 - 25Relocation Assistance Provided Not Provided US Citizenship Required? YesClearance Required? No Clearance LevelEntry-Level (0-2 years) WorkstyleOnsite
*Job Overview* We are seeking a skilled and detail-oriented Cabinet Maker to join our team. The ideal candidate will have a strong background in woodworking and carpentry, with experience in cabinet installation and fabrication. Must be able to use all basic tools without instruction that are necessary for woodworking and cabinet making and cabinet installation. Such as table saw, miter saw, router, Etc. Must have ability to scribe wood to uneven surfaces. Experience with Blum hardware installation is a must. This role requires a commitment to quality craftsmanship and the ability to work collaboratively on various projects. The Cabinet Maker will be responsible for creating custom cabinets and fixtures according to specifications, ensuring high standards of quality and precision. *Responsibilities* * Read and interpret blueprints, schematics, and technical drawings to determine project specifications. * Construct, assemble, and install cabinets, doors, and other wooden fixtures. * Operate hand tools and power tools safely and effectively for cutting, shaping. * Perform trim carpentry and frame carpentry tasks as needed on-site. * Collaborate with other tradespeople on construction sites to ensure project timelines are met. * Maintain a clean and organized workspace while adhering to safety regulations. * Engage in heavy lifting as required during the installation process. *Requirements* * Proven experience in carpentry or woodworking with a focus on cabinet making. * Proficiency in using hand tools, power tools and other fabrication equipment. * Strong understanding of construction processes. * Ability to read blueprints and schematics accurately. * Excellent problem-solving skills with attention to detail. * Ability to lift heavy materials safely (up to 50 pounds). * Strong communication skills for effective collaboration with team members. Join our team of dedicated professionals where your skills will be valued and your contributions recognized. We look forward to welcoming a new Cabinet Maker who is passionate about their craft! Job Types: Full-time, Part-time Pay: $20.00 - $40.00 per hour Expected hours: No less than 30 per week Work Location: In person
Overview: Position Summary: The TEM Production Supervisor is responsible for daily production and inventory management ensuring goals are met, quality, production, efficiency, and timely delivery of existing and new/modified products to stock. The TEM Production Supervisor is also responsible for leading department staff in support of manufacturing activities. This is a 3rd shift role, from 9:30 pm-6 am. The salary range for this position is currently $80,000- $100,000 annually. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs. Responsibilities: Key Accountabilities Essential Functions: Execute assigned weekly production plan as per weekly schedule. Ensure all department work is done in accordance with Good Manufacturing Practices (GMP) and all related standard operating procedures (SOPs). Continually work to achieve assigned production goals; meet unscheduled peaks in workload as necessary to ensure timely release of product and to avoid back orders. Manage inventory to insure quality, production, and efficiency. Maintain adequate staffing needs in support of business objectives; work to avoid overtime hours, achieve assigned production goals, meet unscheduled peaks in workload, ensure timely release of product, and to avoid back orders. Coordinate qualification and validation trials. In accordance with company policy, process and approve staff work hours in companys time-clock system; approve time off requests ensuring business needs are continually met. Maintain effective manufacturing and control of products in compliance with all established manufacturing specifications and control procedures. Identify department training needs and implement appropriate training measures; mentor and train staff to enhance both individual and department performance. Oversee maintenance of department training records. Identify and address staffing needs with management. Continually evaluate performance of direct reports; take appropriate disciplinary action in accordance with company policy as necessary. Ensure safe working conditions throughout the department at all times ensuring adherence to all safety policies and procedures; work with management to identify and address safety matters and concerns. Ensure support for the transfer of technology (product) to routine manufacturing; evaluate new technologies and the pilot work that is required to assure minimum problems with initial and subsequent manufacturing. Manage special projects as assigned by management. Ensure accurate records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs. Identify production and manufacturing issues and work to implement corrective action. Work cross-functionally to coordinate corrective action for technical problems related to raw materials, finished products; minimize rejects and field complaints. Ensure and maintain compliance with the Companys quality system requirements through training and adherence to policies, procedures and processes. Other duties as assigned. Qualifications: Minimum Knowledge & Experience Required for the Position: High school diploma or equivalent; additional training/education a plus. Minimum of five (5) years previous related manufacturing supervisory experience within a regulated medical device manufacturing or pharmaceutical environment. Previous lead or supervisory experience, including experience with staffing and time management. Knowledge of lean manufacturing principles preferred. Demonstrated ability to support business goals and objectives related to cost and manufacturing processes. Understanding of coagulation-based manufacturing processes and company products. Good understanding of GDP, GMP, Good Laboratory Practices (GLP), FDA, and ISO. Working knowledge of Microsoft Office and experience with large Enterprise Resources Planning (ERP) system. Good written and verbal communication. Ability to work as part of a team. Ability to identify and correct problems. Good leadership abilities.
*Job Overview* As a Manufacturing Engineer, you’ll optimize production by reviewing and improving manufacturing processes and tooling. Working hands-on on the factory floor, you’ll identify Lean opportunities and recommend changes to reduce costs, improve setup and cycle times, and eliminate non-value-added activities. You'll also demonstrate and instruct optimal manufacturing methods, with the ability to fabricate parts and perform production tasks as needed. *Responsibilities and Duties* * Provide recommendations to minimize costs, enhance setup/cycle times, and eliminate non-value-added processes from the manufacturing workflow. * Create sketches, PDFs, and 3D CAD models using engineering software like SolidWorks and Mastercam to support manufacturing processes and design improvements. * Interpret and comprehend engineering 2D drawings, BOM’s, and assembly prints to ensure alignment with manufacturing requirements. * Assess existing job processes to identify opportunities for streamlining and efficiency improvements. * Work with engineering team members to develop manufacturing process for proposed and new jobs. * Create and document new procedures to refine and standardize manufacturing operation. * Demonstrate a keen eye for quality, comprehending and applying specific Quality Control (QC) specifications to each Job/Part number. *Qualifications* * Ability to perform all essential listed job duties and responsibilities listed above * Proficient with Microsoft Office applications such as Word, Excel and PowerPoint, and Teams * Familiar with the methods and procedures associated with AS9100 * BS degree in engineering or related field with minimum 4 years of experience as Manufacturing Engineer * Familiar with, and ideally proficient in, solid modeling and toolpath programs * Familiarity with SolidWorks and Mastercam as well as 3- and 5-axis CNC programing * Strong verbal and written communication skills, with the ability to produce well-organized, grammatically correct documents, reports, and emails * Self-motivated individual capable of working under limited supervision * Able to organize and execute tasks efficiently and possess good time management skills * Collaborative team player, able to work well with colleagues at all levels * Basic proficiency with manual machine tools and hand tools Job Type: Full-time Pay: $75,000.00 - $95,000.00 per year Benefits: * 401(k) * 401(k) matching * Dental insurance * Flexible spending account * Health insurance * Life insurance * Paid time off * Referral program * Vision insurance Application Question(s): * Do you have BS degree in engineering or related field with minimum 4 years of experience as Manufacturing Engineer? * Are you familiar with SolidWorks and Mastercam as well as 3- and 5-axis CNC programing? * Are you proficient with Microsoft Office applications such as Word, Excel and PowerPoint, and Teams? * Are you familiar with the methods and procedures associated with AS9100? Ability to Commute: * Carlsbad, CA 92011 (Required) Work Location: In person
Job Description How does it feel to work on a team driven to make a big impact? Empowering. We believe your career should always be growing. And that’s exactly what it will do at BAE Systems as part of our Leadership Development Program (LDP). The LDP is designed to accelerate the development and career of highly-motivated entry level talent who aspire to achieve their leadership potential. This is accomplished through challenging and rewarding rotational assignments, technical and leadership training, advanced education, leadership opportunities and exposure, and mentorship. You’ll hit the ground running with a company truly committed to your growth as you enjoy a special camaraderie on a team dedicated to protecting what really matters. The Quality Leadership Development Program (QLDP) is a three-year rotational program designed to develop high potential, entry-level individuals into future leaders in Quality Engineering. You’ll have the opportunity to experience assignments in several operational functions, business areas, and product groups nationwide. QLDP participants are also exposed to a variety of networking opportunities and strategic project initiatives across the sector. The QLDP consists of three, one-year, rotations; each with increasing responsibility. It is designed to provide a diverse set of experiences within Quality Engineering and related disciplines. Candidates should display an interest in undertaking rotations in the following areas: Program Quality Engineering Manufacturing Product Assurance Supplier Quality Assurance Quality Management Performance Analysis Participants input is included in the choice of their 2nd and 3rd rotational assignments and/or geographic location. In addition to the functional rotations, members of the QLDP participate in the following opportunities: Lean Six Sigma: Participants are required to pursue an internally sponsored Green Belt project and receive certification. Upon receiving Green Belt certification, participants can pursue their Black Belt. Monthly Trainings: The QLDP provides participants with a monthly training curriculum to develop technical and leadership skills. Personal growth: The program seeks to facilitate the growth of an individual's leadership skills through an annual, week-long leadership development conference (LDC). This conference provides personalized leadership training as well as an opportunity to network with senior BAE Systems executives and other leadership development program participants across the company. Mentorship: A mentor is assigned to each QLDP participant to expose them to diverse and challenging experiences, while providing guidance in choosing rotations, career development, and post-program placement. Education: Participants are strongly encouraged to complete a graduate degree on a part-time basis. The school and specific technical degree is left up to the candidate, providing it is applicable to the business. BAE Systems provides tuition assistance for this degree. Opportunity to travel: BAE Systems has locations worldwide with our QLDP members primarily rotating to locations within the United States. Your first rotation will be at one of our major locations: Nashua, NH; Austin, TX; San Diego, CA; Wayne, NJ; Huntsville, AL; Endicott, NY; Greenlawn, NY; Manassas, VA. These assignments can change based on business need. Your second and third rotations may be at any of our locations nationwide. All candidates must be able to: Relocate during the rotational program Start at one of our major locations: Nashua, NH; Austin, TX; San Diego, CA; Wayne, NJ; Huntsville, AL; Endicott, NY; Greenlawn, NY; Manassas, VA Obtain and maintain a Department of Defense security clearance Required Education, Experience, & Skills Master’s degree in Engineering (Mechanical, Industrial, Systems, Electrical, Quality Management, or other applicable majors) Internship/Co-Op or project experience in related field Demonstrated teamwork and leadership abilities in academic pursuits Participation in a variety of extracurricular activities All candidates must be able to: Relocate during the rotational program Start at one of our major locations: Nashua, NH; Austin, TX; San Diego, CA; Wayne, NJ; Huntsville, AL; Endicott, NY; Greenlawn, NY; Manassas, VA Obtain and maintain a Department of Defense security clearance Preferred Education, Experience, & Skills Superior communication skills Capacity and motivation for hard work Knowledge of Quality Management Systems Familiarity with Lean and Six Sigma practices Experience in defense electronics industry Pay Information Full-Time Salary Range: $77809 - $132275 Please note: This range is based on our market pay structures. However, individual salaries are determined by a variety of factors including, but not limited to: business considerations, local market conditions, and internal equity, as well as candidate qualifications, such as skills, education, and experience. Employee Benefits: At BAE Systems, we support our employees in all aspects of their life, including their health and financial well-being. Regular employees scheduled to work 20+ hours per week are offered: health, dental, and vision insurance; health savings accounts; a 401(k) savings plan; disability coverage; and life and accident insurance. We also have an employee assistance program, a legal plan, and other perks including discounts on things like home, auto, and pet insurance. Our leave programs include paid time off, paid holidays, as well as other types of leave, including paid parental, military, bereavement, and any applicable federal and state sick leave. Employees may participate in the company recognition program to receive monetary or non-monetary recognition awards. Other incentives may be available based on position level and/or job specifics. About BAE Systems Electronic Systems BAE Systems, Inc. is the U.S. subsidiary of BAE Systems plc, an international defense, aerospace and security company which delivers a full range of products and services for air, land and naval forces, as well as advanced electronics, security, information technology solutions and customer support services. Improving the future and protecting lives is an ambitious mission, but it’s what we do at BAE Systems. Working here means using your passion and ingenuity where it counts – defending national security with breakthrough technology, superior products, and intelligence solutions. As you develop the latest technology and defend national security, you will continually hone your skills on a team—making a big impact on a global scale. At BAE Systems, you’ll find a rewarding career that truly makes a difference. Electronic Systems (ES) is the global innovator behind BAE Systems’ game-changing defense and commercial electronics. Exploiting every electron, we push the limits of what is possible, giving our customers the edge and our employees opportunities to change the world. Our products and capabilities can be found everywhere – from the depths of the ocean to the far reaches of space. At our core are more than 14,000 highly talented Electronic Systems employees with the brightest minds in the industry, we make an impact – for our customers and the communities we serve. This position will be posted for at least 5 calendar days. The posting will remain active until the position is filled, or a qualified pool of candidates is identified.
**Ink Technician -2nd Shift from 4:00 PM to 2:30 AM Monday to Thursday. ** Join Our Team! Precision Label, an Inovar Packaging Group, LLC Company, is proud to be one of North America’s premier flexographic and digital printing companies, dedicated to the success of our employees and customers. We invest in the latest equipment and technology, continually seeking the best strategies and solutions to deliver cutting-edge, top-quality products. Our culture is customer-driven, team-oriented, and built on win-win partnerships. Why Join Us? Competitive pay Comprehensive benefits package, including medical, dental, vision, life insurance, and short/long-term disability 401(k) Retirement Plan with a generous company match Paid Time Off (PTO) and company holidays Opportunities for career growth within a rapidly expanding company A collaborative and innovative work environment Position Overview The 2nd Shift Ink Technician is responsible for preparing, mixing, and maintaining inks to ensure color consistency and quality standards across all flexographic and digital printing projects. This role plays a key part in supporting production efficiency, minimizing waste, and delivering products that meet or exceed customer expectations. Key Responsibilities Mix and match inks according to job specifications, using precision tools and measurement systems. Maintain ink inventory, including ordering, tracking, labeling, and storage in compliance with safety standards. Conduct color matching and quality checks to ensure consistency with customer requirements and press standards. Partner with press operators and production staff to troubleshoot ink-related issues and ensure smooth workflow. Follow standard operating procedures (SOPs) to reduce downtime, optimize ink usage, and minimize waste. Maintain cleanliness and organization of ink room, equipment, and supplies. Assist with press-side support as needed, including adjustments and ink replenishment. Adhere to all company safety, quality, and environmental guidelines. Qualifications Minimum of 2 years prior experience ink mixing in a printing or manufacturing environment. Must be willing and able to work 2nd Shift from 4:00PM to 2:30AM Monday to Thursday.(Training will be on 1st shift from 6:30AM to 4:00PM for the first 3 weeks) High school diploma or equivalent; technical training in printing or related field preferred. Strong attention to detail with ability to match colors accurately. Basic math and measurement skills. Ability to work independently and in a team-oriented environment. Strong organizational skills with the ability to manage multiple priorities. Commitment to safety, quality, and continuous improvement. Inovar Packaging Group is an equal-opportunity employer. All job offers are contingent upon passing pre-employment screening, including a drug test and background check.
Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics®. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments for over 25 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used by over 700 clinical laboratories in over 160 countries. Our global network of laboratories offers internationally standardized next generation molecular and flow cytometry panels to support drug development and accelerate drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs and treatments for cancer patients. Our harmonized ISO15189 accredited and CLIA/CAP clinical laboratories offer a test menu focused on biomarkers which are clinically actionable to support therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all designed to accelerate approvals of new oncology drugs and treatments. For 25 years, we have been at forefront of precision diagnostics, and we’re just getting started! We are looking for an *Automation Engineer* to work closely with Manufacturing, Project Management, MTS, Quality, Facilities, R&D, and third-party vendors on the design, development, manufacturing, and implementation of an automated fill and finish machine tailored for reagent manufacturing. S/he will play a critical role in translating manufacturing requirements into automated solutions that enhance quality, throughput, and compliance while reducing manual interventions. This role is project-based with a defined timeline and deliverables. *Essential Job Function:* *System Design & Requirements* * Assess current reagent manufacturing processes and identify automation opportunities for fill and finish operations. * Define user requirements specifications (URS) for automated systems, including throughput, accuracy, compatibility, sterility, and GMP compliance. * Recommend hardware, robotics, sensors, and control platforms suitable for reagent filling and capping processes. * Evaluate facilities requirements for the selected equipment. *Implementation & Integration* * Develop process flow diagrams and detailed design documents for automated fill and finish systems. * Oversee vendor selection, equipment procurement, and integration of automation components. * Ensure seamless connectivity with upstream and downstream manufacturing systems *Validation & Compliance* * Develop and support execution of IQ/OQ/PQ protocols to validate automated equipment. * Ensure adherence to GMP, ISO, and relevant regulatory standards (e.g., FDA, ISO 13485). * Document all processes, design decisions, and risk assessments for regulatory submission and audits. *Optimization & Support* * Implement process monitoring and data acquisition systems to support continuous improvement. * Train internal staff on system operation, troubleshooting, and maintenance. * Provide recommendations for scalability and future expansion of automated manufacturing. *Qualifications:* * Bachelor’s degree in Automation Engineering, Mechanical Engineering, Electrical Engineering, or related field of study and, typically, 8+ years’ experience in automation, robotics, or process engineering within life sciences, pharmaceuticals, or diagnostics manufacturing. Advanced degree is advantageous. Equivalent combination of education and experience may be considered. * Proven experience with fill and finish equipment (liquid handling, cassette/cartridge filling, sealing, labeling). * Familiarity with automation control systems (PLC, SCADA, HMI) and system integration. * Strong knowledge of GMP, FDA, and ISO 13485 requirements. * Demonstrated success in leading projects from concept to validated production systems. Invivoscribe is an Equal Opportunity Employer. Job Type: Contract Pay: $60.00 - $100.00 per hour Work Location: In person
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Manager of Production Service will provide support to the Manufacturing Operations by leading the production services team in operational and continuous improvement activities. The focus of this position is to ensure facility cleaning is performed, materials are stock and staged for use in unit operations, solution formulations are manufactured and released for use in unit operations and startup / breakdown operations occur to maintain the production schedule, and monitoring operations occur during the off shift. Direct reports include Lead (Senior Production Service Associate) as well as Production Service Associates I & II Responsibilities Manage large volume liquid (buffer/media) manufacturing in support of Upstream Cell Culture and Downstream Purification operations Manage schedule use for production equipment with single-use materials as it relates to buffer and media preparations, including weight and dispense. Manage schedules to maintain daily, weekly, and monthly cleanings of the cleanroom and surrounding controlled areas, including floors, walls, ceilings and equipment. Manage batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging. Manage, lead, mentor, and train all manufacturing employees in execution of buffer and media preparation. Manage and ensure documentation/verification of task completion is performed in accordance with cGDP, SOPs and Batch Records. Set up and use equipment in accordance with established practices. (i.e. RTP, STR, Production Bioreactors, AKTA systems, Depth Filters and Pods, Viral Filtration, and UFDF) Oversee specifically assigned projects, to include monitoring project timelines, ordering supplies, and communication of project status to senior management. Network with MSAT, Manufacturing, and Quality organizations to establish a reliable state of process control Participate in technical transfer and implementation of media and buffer preparation strategies. Oversee activities involving buffer mixers, filtration systems, raw material management and intermediate solution delivery Draft, review and approve SOPs, master batch records, and other cGMP documentation Prepare technical reports, summaries, protocols, batch records and quantitative analyses as needed. Change owner for implementation or revision of equipment, documentation, and material specifications Propose implementation of production procedures to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success Develop effective working relationships with internal partners Represent departmental activities as needed, including project teams, task forces, audits and business or technical meetings with outside groups, as needed. Provide input and feedback on performance of production associates. Demonstrate administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena strategic goals Adhere and train staff on appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms. Ensure documentation/verification of task completion is performed in accordance with cGDP, SOPs and Batch Records. Forecast work scheduled activities in support of production schedules. Support floor operations for multiple projects simultaneously. Monitor processes and results and troubleshooting issues as they arise to ensure process success. Instruct associates through process and workflow improvement initiatives. Enforce cleanroom standards for cleanliness and order Review GMP records for completeness, accuracy, and compliance daily in conformance with regulatory requirements. May cross-train on various tasks supporting Upstream and Downstream cGMP manufacturing to support overall success of the Biologics group Operate to the highest ethical and moral standards Comply with Abzena's policies and procedures Communicate effectively with supervisors, colleagues and staff Participate effectively as a team player in all aspects of Abzena's business Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Perform other duties as assigned Qualifications BA/BS or MA/MS degree that included laboratory work in biology, microbiology, chemical engineering or related field. Minimum 6 years of experience in manufacturing operations, preferably in a GMP environment. Experience leading and developing associates, minimum 2 years of experience Experience organizing workload, oversee workload of direct reports, and relevant resource requirements. Experience in leadership duties, including time management and planning. Physical Requirements Physical ability to walk, stand and sit for extended periods of time. Ability to work in an office setting where sitting and computer usage would be the norm. Use arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus FLSA: Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Production Services Associate I will be responsible for supporting both downstream and upstream production in a cGMP manufacturing environment. The Production Services team prepares buffers and media, cleaning and sanitization of the facility, assembling equipment kits to support manufacturing operations, setting up and breaking down of operational equipment, in accordance with the operations schedule. This role requires adherence to cGMP and standard operating procedures. Responsibilities Perform a variety of complex tasks in accordance with cGMP. Operate and maintain production equipment with single-use materials as it relates to buffer and media preparations, including weight and dispense. Perform daily, weekly, and monthly cleanings of the cleanroom and surrounding controlled areas, including floors, walls, ceilings and equipment. Maintain and stock supplies as directed. (i.e. gowning, and emergency kits, ect.) Documentation/verification of task completion in accordance with cGDP, SOPs and Batch Records. Manage a flexible work schedule where shift work may be required. Conduct activities in support of production schedules as directed by senior staff. Support floor operations for multiple projects simultaneously. Crosstrain on various tasks including Upstream/Downstream cGMP manufacturing. Operate in a team setting. Follow detailed instructions and to maintain accurate records. Set up equipment in accordance with established practices. (i.e. RTP, STR, Production Bioreactors, AKTA systems, Depth Filters and Pods, Viral Filtration, and UFDF) Safely handle and transport raw materials, finished product and equipment in and out of the cleanroom, adhering to aseptic technique. Operate to the highest ethical and moral standards. Comply with Abzena's policies and procedures. Communicate effectively in a team environment. Participate effectively as a team player in all aspects of Abzena's business. Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Perform other duties as assigned. Qualifications 0 – 2 years of experience in manufacturing production. A high school diploma is required. Knowledge and understanding of cGMPs. Experience using single-use technologies and disposable systems. Ability to compute basic arithmetic operations: addition, subtraction, multiplication, and division. Physical Requirements Physical ability to walk and stand for extended periods of time. Frequently lift and or move objects up to 30 pounds. Use arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus. Values above to not include shift differentials FLSA: Non-Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Senior Production Service Associate will primarily be responsible for organizing and leading production services and training associates involved in all aspects of production in a single use facility, including buffers and media, cleaning and sanitization of the facility, assembling equipment kits to support manufacturing operations, setting up and breaking down operational equipment in accordance with the operations schedule Responsibilities Perform a variety of complex tasks in accordance with cGMP Operate/ maintain/ and schedule use for production equipment with single-use materials as it relates to buffer and media preparations, including weight and dispense. Schedule and maintain daily, weekly, and monthly cleanings of the cleanroom and surrounding controlled areas, including floors, walls, ceilings and equipment. Lead batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging. Provide hands-on training for staff to ensure compliance with training on all activities prior to GMP execution. Ensure documentation/verification of task completion is performed in accordance with cGDP, SOPs and Batch Records. Schedule day-to-day work scheduled activities in support of production schedules. Support floor operations for multiple projects simultaneously. Competent in Upstream and Downstream Operations Provide cross train on various tasks including Upstream/Downstream cGMP manufacturing. Adhere and train staff on appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms. Set up and use equipment in accordance with established practices. (i.e. RTP, STR, Production Bioreactors, AKTA systems, Depth Filters and Pods, Viral Filtration, and UFDF) Safely handle and transport raw materials, finished product and equipment in and out of the cleanroom, adhering to aseptic technique Monitor processes and results and troubleshooting issues as they arise to ensure process success. Provide detailed observations, analyze data and interpret results. Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways. Guide associates through process and workflow improvement initiatives. Enforce cleanroom standards for cleanliness and order Communicate effectively with supervisors, colleagues, and staff to provide status of floor operation to management on a regular basis. Direct floor operations for multiple projects simultaneously. Adjust as necessary to adhere to production schedules. Review GMP records for completeness, accuracy, and compliance daily in conformance with regulatory requirements. Draft, revise and review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation. Identify and initiate deviations, assist in assessing product quality impact, and assisting with proposals for Corrective and Preventative Actions (CAPA). Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Operate to the highest ethical and moral standards. Adjust to a flexible work schedule including weekend work, as needed. Perform additional duties as assigned. Qualifications BA/BS degree in chemistry, biology, or related field. At least 4 – 5 years of experience in a GMP pharmaceutical/biotech environment role. Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities. Skilled with using single-use technologies Strong technical and mechanical aptitude in bioprocessing. Knowledge of upstream and/or downstream operations. Experience leading, training, and coaching peers. Computer proficiency A proven ability to confidently compute basic arithmetic operations. Physical Requirements Physical ability to walk, stand and sit for extended periods of time. Frequently lift and or move objects at least 30 pounds in weight. Use arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus. Values above to not include shift differentials FLSA: Non-Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Production Services Associate II is responsible for supporting both downstream and upstream production in a cGMP manufacturing environment. The Production Service team prepares buffers and media, cleaning and sanitization of the facility, assembling equipment kits to support manufacturing operations, setting up and breaking down of operational equipment in accordance with the operations schedule. This role requires strict adherence to cGMP and standard operating procedures. Responsibilities Perform a variety of complex tasks in accordance with cGMP Operate and maintain production equipment with single-use materials as it relates to buffer and media preparations, including weight and dispense. Maintain/Perform daily, weekly, and monthly cleanings of the cleanroom and surrounding controlled areas, including floors, walls, ceilings and equipment. Order, maintain, and stock supplies as directed (i.e. gowning, emergency kits, ect.) Documentation/verification of task completion in accordance with cGDP, SOPs and Batch Records. Monitor and maintain appropriate inventory levels of raw materials required for buffer and media prep. Manage a flexible work schedule where shift work may be required. Conduct activities in support of production schedules as directed by senior staff. Support floor operations for multiple projects simultaneously. Crosstrain on various tasks including Upstream/Downstream cGMP manufacturing. Operate in both a team and individual setting. Follow detailed instructions and maintain accurate records. Set up and use equipment in accordance with established practices. (i.e. RTP, STR, Production Bioreactors, AKTA systems, Depth Filters and Pods, Viral Filtration, and UFDF) Safely handle and transport raw materials, finished product and equipment in and out of the cleanroom, adhering to aseptic technique. Operate to the highest ethical and moral standards. Communicate effectively the status of floor operations to leads. Participate effectively as a team player in all aspects of Abzena's business. Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Perform other duties as assigned. Qualifications 2-4 years of experience in cGMP manufacturing environment, preferably with buffer/media prep. A high school diploma is required. Technical degree in related field preferred. Knowledge and understanding of cGMPs. Experience using single-use technologies and disposable systems. Wear and maintain the required PPE to protect product integrity and ensure personal safety. Physical Requirements Physical ability to walk and stand for extended periods of time. Frequently lift and or move objects up to 30 pounds. Use arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus. Values above to not include shift differentials FLSA: Non-Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
Production Planner Monday – Friday, 7:30 am - 4:00 pm About Us At Argen, we’re in the business of creating healthy, confident smiles one case at a time. Argen is a global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada, Germany, UK, and China, and sales in 105 countries worldwide. We have a team of 400 Awesome team members. Founded more than 50 years ago as a precious metals company in South Africa, Argen has grown to become the largest dental zirconia manufacturer in North America, largest dental alloy provider worldwide, and leader in digital dentistry solutions with a product offering that span fixed, removable, ortho, implants, and equipment. Our 140,000 square foot manufacturing center houses more than 150 3D printing and milling machines and operates six days a week. Argen’s products are held to the highest standards of quality, and are FDA 510(k) cleared, ISO 13485 certified, and MDSAP compliant. Argen embodies a culture of innovation, continuous improvement, and LEAN practices in support of our mission to help our dental laboratory customers succeed. About the Opportunity Creates, reviews, amends, and maintains attainable and effective production schedules for assigned products and product families, which has a significant impact on customer service and shop floor activity and therefore must be a creative thinker with sound decision making ability that acts with the customer in mind. In this role, the successful candidate will: Executes ERP and the timely creation of shop orders to satisfy customer demand, achieve desired levels and maintain flow of work on the factory floor. Utilizes system tools inclusive of material requirements planning and capacity planning to ensure that the supply chain is effective in meeting the needs of our customers while maintaining required delivery and inventory goals. Communicates and coordinates with production supervisors and purchasing team to ensure schedule adherence and recovery if required. Initiates and participates in continuous improvement activities related to production planning, customer service and inventory management. Reviews and maintains QAD data integrity inclusive of routings and bill of material accuracy. Manages and maintains inventory levels ensuring uninterrupted supply of parts while maintaining optimal inventory levels, along with ensuring customer reliability and meeting target inventory turns. Tracks progression of production orders, investigate factors that affect schedules, and modify plans as necessary. Expedites critical orders throughout the supply chain. Informs management of potential production problems and assist in the implementation of both short- and long-term solutions. Analyzes forecasted demand to ensure safety stock and strategic inventory levels on finished goods are maintained. Performs planning functions required to achieve the timely and successful launch of new products and participates as assigned on new product development teams. Other duties as assigned. What does it take to be successful? High school diploma or equivalent required. Bachelor’s Degree from an accredited institution in a related field is preferred. 3 + years of experience in production scheduling in a manufacturing environment required. APICS/CPIM certification preferred. Experience using QAD, preferred or SAP (forecasting tools and system overall). Experience in ERP Planning. Experience using analytical spreadsheet tools as well as other MS Office applications. Experience working with Microsoft Access and writing queries to analyze data. Ability to handle multiple tasks along with excellent time management skills and customer service skills. Strong interpersonal and conflict resolution skills to effectively interface with production, customer service, and management. Ability to conceptualize, define and resolve complex problems. Excellent analytical, problem solving and facilitation skills. Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred. Our Awesome Benefits! Working for a growing innovative company like Argen means exciting opportunities for training and learning, career development and advancement from only the best in the dental industry. With all that hard work, Argen is committed to ensuring the welfare of its employees and provides an amazing benefit package that includes: Health Plans Dental Plans Vision Plan 401k with Employer Match Paid Time Off and Paid Holidays Employee Events Wellness Programs Discounts for home, travel, entertainment, relaxation that includes Mobile phone service, Technology, Airline and Hotel, Theater/Theme Park tickets, Restaurants and so much more! EOE/M/F/Vet/Disabled VEVRAA Federal Contractor Mon-Fri 7:30am-4:00pm