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2 weeks ago

Contract Lab Technician I

FLUIDRA - Carlsbad, CA 92010

Fluidra is looking for a Contract Lab Technician I to join our team in Carlsbad, CA. WHAT YOU WILL CONTRIBUTE While working and participating in a team environment, the Lab Maintenance Technician will play a vital role in the research and development of Fluidra products. They will be responsible for providing support services to Lab Engineers and Lab Test Technicians, and to help keep the lab running and properly maintained. Below is a breakdown of specific tasks the Lab Maintenance Technician will be responsible for, along with an estimated percentage of time to be spent on each task. Additionally, you will: Assist with the set-up, tear down, and maintenance of test fixtures. 35% Maintain basic water chemistry and ensure proper filtration of lab test tanks. 20% Assist in tearing down, recycling, and disposing of discarded products and equipment 15% Assist test engineers in the conducting of product validation tests as needed 15% Utilize Microsoft Office Applications (Excel, Word, etc), to document water chemistry readings and equipment maintenance records 5% Help maintain lab cleanliness by complying with 5S standards. 5% Assist engineering team in packaging and shipping product prototypes and samples. 5% WHAT WE SEEK Entry level position, but needs high technical acumen and ability to work with hands Comfortable using basic hand tools including, wrenches, drills, saws, screw drivers, etc… Must be comfortable being trained on basic electrical wiring and plumbing tasks. Exceptional observation, communication and troubleshooting skills. Machine shop experience is a plus, but not necessary. Proficient in Microsoft Office products and Windows XP environments. Read, write and communicate fluently and clearly in English. EDUCATION High School Diploma Technical or Trade School a plus WHAT WE OFFER An exciting opportunity to dive in and begin your career with a company that offers a competitive total rewards package that includes: Alternate work week schedule (EVERY OTHER FRIDAY OFF!) On-site self-service café / free gourmet coffee stations Company sponsored FUN events! On-site gym, ping-pong, foosball, outdoor bocce ball court, BBQ & firepit WHO WE ARE Fluidra is a publicly listed company focused on developing innovative products, services and IoT solutions for the residential, commercial and wellness pool markets, globally. The company operates in over 45 countries, has over 7,000 employees and owns a portfolio of some of the industry’s most recognized and trusted brands: Polaris®, Jandy®, CMP®, S.R. Smith®, and Zodiac®. We also sell products under the Cover‐Pools®, iAquaLink®, Grand Effects®, Del® and Nature2® names. With these combined resources we’re able accelerate innovation in critical areas like energy-efficiency, robotics and the Internet of Things. Our focus is on creating the perfect pool and wellness experience responsibly. We take our mission to heart, and our employees embody these guiding principles in everything we do: passion for success, honesty & trust, customer collaboration, teamwork and inclusion, learn and adapt, excellence and innovation. Don't meet every single requirement listed? At Fluidra, we thrive on building an inclusive workspace, so if you are excited about this role and your past experience doesn't align perfectly, we encourage you to apply anyways! You may be just the right candidate for this role or another role in the organization. Fluidra is proud to be an equal opportunity employer. Fluidra recruits, employs, trains, compensates and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, or any legally protected characteristic. Expected hourly rate is $25.00. The actual salary offer will carefully consider a wide range of factors, including skills, qualifications, experience and location. Your recruiter will provide additional details on our compensation.

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2 weeks ago

Extrusion Lead

Winchester Interconnect - San Marcos, CA 92078

At Winchester Interconnect, we always do the right thing, the right way. Winchester Interconnect is committed to inspiring the most innovative teams. We foster a dynamic, inclusive environment that thrives on collaboration and continuous growth. We hire exceptional people, celebrate wins, empower employee growth, and provide opportunities to thrive. Winchester is where potential transforms into purpose, and every team member plays a vital role in shaping our shared success. Position Summary: As our Extrusion Lead you will be responsible for all aspects of managing the extrusion department (safety, quality, on time delivery and productivity). Responsible for leading the continuous improvement culture and driving employee engagement and ownership. Qualifications & Requirements: Manage the day-to-day operations of the department Monitors operations for efficiency and safety, ensuring that all applicable regulatory requirements. Continuously drive to improve department metrics, productivity, safety, delivery, quality and cost containment. Oversee production staff, including hiring/training of personnel. Leadership in implementing Lean Continuous Improvement actions. Our core values - Accountability, Collaboration, and Empowerment (ACE) - are the foundation of how we operate and drive success. You will take ownership of your contributions, collaborate with a team that gets stuff done, and be empowered to innovate and pursue bold initiatives that drive our business forward. Are You Our Next ACE? Accountable for adhering to leader standard work, ensuring strict safety protocols are followed, and maintaining the highest quality standards in product creation. Additionally, you are responsible for executing the production schedule on a daily, weekly, and monthly basis, while embodying the Winchester Values. Collaborate by managing the extrusion department will involve ensuring safety, quality, on-time customer shipments, and productivity through effective planning and execution. This collaborative approach will also focus on fostering a continuous improvement culture and promoting employee engagement and ownership to achieve manufacturing goals and financial results. Empowered to strategically build your organization by actively recruiting top talent to support long-term growth. Additionally, you have the empowerment to identify investment opportunities for process improvement, set clear team goals, simplify processes, utilize resources effectively, and maintain transparent communication regarding expectations and performance. Systems You'll Use: Google Enterprise BambooHR Paycom & ADP For a sneak peek into some of our benefits and to learn more about our career opportunities, click here https://www.winconn.com/jobs/. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. In addition to federal law requirements, Winchester Interconnect complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. Winchester Interconnect expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. ***Candidate Inquiries Only-No Third-Parties*** Compensation: $24.00/hr-$26.46/hr

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2 weeks ago

MES Engineer

Genentech - Oceanside, CA

THE POSITION The Opportunity: This position, based in Genentech's Oceanside, California facility, provides the opportunity to have a key role in a highly automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The candidate will report to the Site Head of IT OT, an organization that is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as standardizing and leveraging new technologies. As part of the Oceanside IT OT team, you will have accountabilities for the Oceanside Manufacturing Execution System (MES), maintaining roadmaps and lifecycle plans, developing proposals, managing related backlogs, leading and/or participating in Build/Run Squads, and ensuring the support of Product Transfers and Make/Assess/Release in a 24x7 Good Manufacturing Practice (GMP) environment. As part of the Site Team and larger Global IT OT organization, you will also be expected to contribute to Manufacturing Operations Management initiatives and optimization/standardization of the global IT OT landscape. What you’ll be working on: Database Development & Administration Design, implement, and optimize SQL Server databases supporting MES. Develop complex SQL queries, stored procedures, functions, and triggers. Perform database tuning, indexing, and query optimization for performance and scalability. Manage backups, restores, disaster recovery plans, and high-availability configurations. Build data extracts and reporting views for manufacturing and quality stakeholders. MES Application Engineering Configure, deploy, and maintain MES software (Emerson Syncade or Pharamsuite). Lead MES upgrades, patch management, and change controls. Troubleshoot MES application issues across the stack (UI, middleware, backend). Systems & Infrastructure Administration Manage Active Directory integration, user/group access control, and system security. Monitor server performance, capacity, and uptime with proactive alerts and logs. Support virtualization (VMware) and system redundancy for critical GMP applications. Compliance & Validation Ensure systems meet GxP and FDA 21 CFR Part 11 requirements. Author/execute technical validation documents (URS, FRS, DS, IQ/OQ/PQ). Support internal and external audits by providing technical and compliance evidence. Cross-Functional Collaboration Integrate MES with ERP, LIMS, DCS, and automation systems. Partner with Manufacturing, QA, Validation, and IT teams to deliver compliant, efficient solutions. Mentor junior engineers on SQL/database best practices, MES configuration, and system administration. Who you are: 5 - 6 years of MES experience in biotech, pharma, or other GMP-regulated manufacturing. Advanced SQL Server skills (query optimization, schema design, indexing, performance tuning). Strong Windows Server and Active Directory administration. Hands-on experience with MES platforms ( Emerson Syncade or Pharmasuite). Proven ability to troubleshoot system issues across multiple layers (application, DB, OS, infrastructure). Strong understanding of GxP, GMP ( CSV methodologies optional ) Preferred Technical Skills Scripting/automation (PowerShell, Python, or Bash). Experience with virtualization platforms (VMware, Hyper-V). Reporting/analytics tools (Crystal Reports). Knowledge of integrating MES with automation and shop floor systems (OPC). Relocation benefits are not available for this job posting. Pay transparency The expected salary range for this position based on the primary location of Oceanside is $80,500.00 - $149,500.000 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. JOB FACTS Job Sub Category Process Development Schedule Full time Job Type Regular Posted Date Oct 24th 2025 Job ID 202510-125994

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2 weeks ago

MES Engineer

Genentech - Oceanside, CA

The Position The Opportunity: This position, based in Genentech's Oceanside, California facility, provides the opportunity to have a key role in a highly automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The candidate will report to the Site Head of IT OT, an organization that is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as standardizing and leveraging new technologies. As part of the Oceanside IT OT team, you will have accountabilities for the Oceanside Manufacturing Execution System (MES), maintaining roadmaps and lifecycle plans, developing proposals, managing related backlogs, leading and/or participating in Build/Run Squads, and ensuring the support of Product Transfers and Make/Assess/Release in a 24x7 Good Manufacturing Practice (GMP) environment. As part of the Site Team and larger Global IT OT organization, you will also be expected to contribute to Manufacturing Operations Management initiatives and optimization/standardization of the global IT OT landscape. What you’ll be working on: Database Development & Administration Design, implement, and optimize SQL Server databases supporting MES. Develop complex SQL queries, stored procedures, functions, and triggers. Perform database tuning, indexing, and query optimization for performance and scalability. Manage backups, restores, disaster recovery plans, and high-availability configurations. Build data extracts and reporting views for manufacturing and quality stakeholders. MES Application Engineering Configure, deploy, and maintain MES software (Emerson Syncade or Pharamsuite). Lead MES upgrades, patch management, and change controls. Troubleshoot MES application issues across the stack (UI, middleware, backend). Systems & Infrastructure Administration Manage Active Directory integration, user/group access control, and system security. Monitor server performance, capacity, and uptime with proactive alerts and logs. Support virtualization (VMware) and system redundancy for critical GMP applications. Compliance & Validation Ensure systems meet GxP and FDA 21 CFR Part 11 requirements. Author/execute technical validation documents (URS, FRS, DS, IQ/OQ/PQ). Support internal and external audits by providing technical and compliance evidence. Cross-Functional Collaboration Integrate MES with ERP, LIMS, DCS, and automation systems. Partner with Manufacturing, QA, Validation, and IT teams to deliver compliant, efficient solutions. Mentor junior engineers on SQL/database best practices, MES configuration, and system administration. Who you are: 5 - 6 years of MES experience in biotech, pharma, or other GMP-regulated manufacturing. Advanced SQL Server skills (query optimization, schema design, indexing, performance tuning). Strong Windows Server and Active Directory administration. Hands-on experience with MES platforms ( Emerson Syncade or Pharmasuite). Proven ability to troubleshoot system issues across multiple layers (application, DB, OS, infrastructure). Strong understanding of GxP, GMP ( CSV methodologies optional ) Preferred Technical Skills Scripting/automation (PowerShell, Python, or Bash). Experience with virtualization platforms (VMware, Hyper-V). Reporting/analytics tools (Crystal Reports). Knowledge of integrating MES with automation and shop floor systems (OPC). Relocation benefits are not available for this job posting. Pay transparency The expected salary range for this position based on the primary location of Oceanside is $80,500.00 - $149,500.000 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

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2 weeks ago

Operations Lead – HPP (2nd Shift)

SUJA Juice - Oceanside, CA 92056

Position Summary The Operations Lead is responsible for overseeing essential functions that keep their assigned department running efficiently, including quality control, production flow, and team coordination. This role requires safely and effectively operating equipment related to HPP, bottling, packaging, and pack-out, while ensuring adherence to safety, quality, and operational standards. Schedule: 1:00 PM - 9:30 PM, Wednesday to Sunday Essential Duties and Responsibilities Including, but not limited to: Operate and maintain fillers, HPP units, labelers, case packers, bundlers, sleevers, palletizers, and related equipment. Perform preventive maintenance (PM) on fillers at the start of each shift. Stand bottles on conveyors and operate the Jet Coder to date bottles and packaging. Coordinate breaks and lunches with bottling department staff. Deliver fiber and packaging materials to production lines. Assist with general labor tasks for bottling, HPP, packaging, and pack-out processes. Support shipping, receiving, inventory, and pack-out activities. Build pallets, lift/move/stack cases weighing up to 50 lbs. Participate in pre-shift meetings, stretching, and shift handoffs. Ensure carriers are full to conserve water. Conduct monthly safety tailgate meetings. Accurately complete required HPP forms and documentation. Maintain consistent and reliable attendance. Working and Environmental Conditions Work performed in a wet, refrigerated manufacturing facility with temperatures below 40°F, with occasional tasks in dry warehouses (up to 85°F) or freezer environments (as low as -10°F). Exposure to noisy environments exceeding 85 dBA. Work areas may be tight; continuous PPE use (safety glasses, ear protection, steel-toed shoes) is required. Must be able to perform repetitive tasks efficiently and safely. May require forklift certification and operation, including maintenance and inspections. Physical Demands Stand and walk for entire shift. Lift and carry up to 50 lbs. continuously; push/pull up to 100 lbs. continuously. Navigate manufacturing environments including bending, kneeling, reaching overhead, stooping, squatting, twisting, climbing ladders/stairs, and working at heights. Regular use of hands for grasping and controlling objects. Occasional desk work requiring computer use. Exposure to moving machinery. Must pass a fit-for-duty physical exam. Benefits We offer a competitive benefits package, including: Medical, dental, vision, life insurance, and other ancillary benefits Matching 401(k) Vacation, sick, and holiday time off Juice benefits Benefits Come join the Suja Life! We offer a competitive benefits package including: Medical, dental, vision, life insurance and other ancillary benefits Matching 401k Vacation, sick and holiday time off Juice Benefits! Compensation $20 - $23/HR DOE #ZR #INDHP Suja Life is proud to be an equal-opportunity employer seeking to create a welcoming and diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, ancestry, physical or mental disability, medical condition, marital status, genetics, age, or veteran status or any other applicable legally protected status or characteristic. The Company complies with all federal/local/state regulations regarding pay. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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2 weeks ago

PC Technician – Manufacturing

Anchor Audio, Inc. - Carlsbad, CA 92008

Anchor Audio is the industry leader in portable sound systems and portable public address (PA) systems. Based in Carlsbad, California, we pride ourselves on manufacturing the highest quality products which are available worldwide. Anchor Audio portable sound systems are proudly manufactured in the United States of America. *Location: *Carlsbad California *Job Title: *PC Associate *Classification: *Full time, non-exempt *Reports to: *PC Manager *Salary Range*: $20.00 – 24.00/hr *Work Schedule*: Onsite (no hybrid work consideration) *Essential Duties:* * Build circuit boards within a standardized time (build templates are used to track your progress) * Review written Standard Operating Procedures (SOPs) regularly, follow instructions, and compare finished work to ensure accuracy * Basic soldering, through-hole * Interpreting basic schematics * Assists with regular machine cleaning/maintenance * Inspects circuit boards for accuracy * Tests circuit boards for reliability and accuracy * Assist with overstock inventory control * Hand-solder specialty components * Successfully operate machinery with careful consideration of all safety training and standards * Assist with special projects and as necessary * May direct work in the absence of the PC manager * Work as a team and independently to complete special projects, assigned goals, and finished product builds * Keep work area clean and organized *Other Duties:* Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. *Education & Experience:* We have identified the following programs, experience, and knowledge which have helped others find success in this role at Anchor Audio. We understand though that knowledge comes from many forms of learning and experiences. Above all, we consider a person’s potential impact in the role and value their unique path to this point in their career. *Required:* * Support Anchor Audio’s C.A.R.E.S Core Values and our commitment to serving our customer, team members, product, and community (our CARES values will be discussed at your welcome/orientation meeting and highlighted throughout your employment) * 3+ years' experience within the PC department or similar role * Ability to build product within a standardized time (build times are tracked daily) * Ability to read, interpret, and utilize schematics * Basic electronic assembly skill * Basic level hand soldering skill * Multimeter and oscilloscope experience * Must be able to lift up to 60 pounds * Must be able to work in a variety of weather conditions/temperatures * Ability to stand, kneel, twist, reach and freely move from one position/department to another * Ability to read, write, and speak English at a level that is sufficient to perform the essential functions of this position, to ensure safety, and efficient operation of business * Excellent time management skills - Prompt attendance is required * Positive attitude – we are a small team, and a positive attitude is a must! * Ability to receive constructive feedback with professionalism, including but not limited to constructive criticism and opportunity for improvement * Full-time, in-office attendance required – no remote work option * Legally authorized to work in the United States * Successful completion and satisfactory results of background check, drug screen, and completion of new hire forms/welcome orientation meeting. *Preferred:* * High school diploma or equivalent * Prior SMT experience * Electronics certification or degree Anchor Audio is an equal opportunity employer. We are committed to creating an inclusive environment for all employees. Our employment decisions are based on individual qualifications, job requirements and business needs without regard to race, color, marital status, sex, sexual orientation, gender identity and/or expression, age, religion, disability, citizenship status, national origin, pregnancy, veteran status and/or any other legally protected characteristics. Job Type: Full-time Pay: $20.00 - $24.00 per hour Benefits: * 401(k) * Dental insurance * Employee assistance program * Employee discount * Health insurance * Life insurance * Paid time off * Professional development assistance * Referral program * Vision insurance Education: * High school or equivalent (Preferred) Experience: * Oscilloscope : 3 years (Preferred) * Multimeter : 3 years (Preferred) * Schematics: 3 years (Preferred) * PCB: 3 years (Preferred) * Soldering: 3 years (Preferred) * Surface mount technology: 3 years (Preferred) * Manufacturing facility: 3 years (Preferred) Ability to Commute: * Carlsbad, CA 92008 (Required) Work Location: In person

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2 weeks ago

Director, Engineering Operations – Encinitas

Scripps Health - Encinitas, CA 92024

Scripps Memorial Hospital Encinitas has served North County’s coastal communities since 1978. We’re located at Santa Fe Drive and I-5, within walking distance of a park, fitness center, grocery store, pharmacy and restaurants. Scripps Memorial Hospital Encinitas’ campus includes Scripps Clinic Encinitas and an outpatient imaging center. We’re home to notable specialty programs including a 24-hour emergency room, accredited stroke care, physical rehabilitation services (including a brain injury day treatment program), our Baby Friendly birthing pavilion and a Level II neonatal intensive care unit. This is a leadership position based out of our Scripps Memorial Campus in Encinitas. Must be available to work Monday-Friday as well as after hours and weekend support as needed. This position is eligible to participate in the Management Incentive Compensation Plan for FY26. Join the Scripps Health team and work alongside passionate caregivers and provide patient-centered healthcare. Receive endless appreciation while you build a rewarding career with one of the most respected healthcare organizations nationwide. Why join Scripps Health? At Scripps Health, your ambition is empowered, and your abilities are appreciated: Nearly a quarter of our employees have been with Scripps Health for over 10 years. Scripps is a Great Place to Work Certified company for 2025. Scripps Health has been consistently ranked as a top employer for women, millennials, diversity, and as an overall workplace by various national publications. Beckers Healthcare ranked Scripps Health on its 2024 list of 150 top places to work in health care. We have transitional and professional development programs to create a learning environment that enables you to thrive in your specific field as well as in your overall career. Our specialties have been nationally recognized for quality in areas such as cardiovascular care, oncology, orthopedics, geriatrics, obstetrics and gynecology, and gastroenterology. Scripps Health provides what matters most: career growth, delivering superior care to our patients, continuous learning, exceptional benefits, and working for an organization that offers many long-term career paths. Join us and experience a culture where opportunities to advance and the support to get there go hand-in-hand. The Director of Engineering Operations will oversee integrity of assigned programs, systems and documentation relevant to the operations so that they are current, complete, and ready for survey at all times. Accountable for timely response to work orders and ensuring all are completed within accreditation and Scripps policy standards. Required Qualifications: Bachelor’s degree in Engineering or a related field In lieu of bachelor’s degree, 10 years increasingly responsible facility maintenance experience, 5 of which managing multi complex California hospital facilities ($10-$50 million operational budget). 5 years continuous leadership experience working in facilities maintenance management in the healthcare industry. Recent progressive leadership and management experience in a healthcare setting. Strong understanding of healthcare regulations and compliance standards Experience with hospital accreditation process, proven ability to lead, and motivate a large team. Exceptional financial management skills, project management, and have strong strategic planning and problem-solving abilities Preferred Qualifications: Master's degree in Engineering or related field Certification in Health Care Facility Management Experience in complex construction projects At Scripps Health, you will experience the pride, support and respect of an organization that has been repeatedly recognized as one of the nation’s Top 100 Places to Work. You’ll be surrounded by people committed to making a difference in the lives of their patients and their teammates. So if you’re open to change, go ahead and unlock your potential. Position Pay Range: $66.73-$96.94/hour

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2 weeks ago

Senior Manager/Associate Director, Regulatory Operations

Fate Therapeutics - San Diego, CA 92121

San Diego, CA Regulatory & Quality – Regulatory / Exempt Full-time / On-site Apply for this job We are seeking a highly skilled Senior Manager / Associate Director of Regulatory Operations to lead the planning, coordination, and execution of global regulatory submissions across our clinical pipeline. This individual will play a critical role in ensuring high-quality, compliant submissions and supporting the development and continuous improvement of our regulatory infrastructure. This is an exempt full-time position located at our corporate headquarters in San Diego, CA. Responsibilities Collaborate with Regulatory Affairs, cross-functional teams, and external partners to plan, prepare, and submit regulatory health authority dossiers and amendments, including INDs, CTAs, IMPDs, and marketing applications in electronic or paper formats, as required (including formatting, life-cycling, and archiving). Oversee in-house technical aspects for health authority submissions, e.g., eCTD document granularity, utilization of content templates, document formatting, eCTD application location and lifecycle assignment, publishing, QC, validation, and transmission to regulatory health authorities (e.g., FDA ESG, EMA IRIS, CTIS). Serve as system owner for regulatory information platforms and tools (e.g., eCTD publishing systems, EDMS, template libraries) and ensure appropriate governance and user support. Maintain up-to-date expertise in electronic submission requirements and computerized system validation standards. Partner with IT to ensure regulatory systems are implemented, validated, and maintained in compliance with SOPs and applicable regulations. Identify potential risks to submission plans and propose/execute risk mitigation strategies. Manage tracking and archiving of regulatory communications and submissions. Support budgeting and forecasting for function and Regulatory Affairs department. Provide recommendations on resource needs for regulatory operations and records management activities, including the need for outsourcing (e.g., eCTD or SPL vendor). Represent Regulatory Operations in project teams to support submission planning and ensure coordination of system development activities. Qualifications B.S. or M.S. degree in IT or Life Sciences related field with 7+ years of relevant and progressive experience in Regulatory Operations. Extensive experience implementing, validating, and managing eCTD publishing systems and EDMS technology (Veeva RIM Suite preferred); familiarity with Lorenz docuBridge and DXC Toolbox a plus. Expert knowledge of global regulatory health authority formatting, publishing, and transmittal requirements for eCTD submissions. Ability to clearly present and articulate regulatory requirements. Knowledge of computer system validation requirements for GxP systems. Familiarity with dossier content requirements for global regulatory health authority submissions; strong knowledge of US and EU content requirements is preferred. Knowledge of CDISC standards and FDA Study Data Technical Conformance Guide (SDTM, ADaM, SEND); experience preparing Study Data Standardization Plans. Advanced proficiency using MS Word, MS SharePoint, Adobe Acrobat Professional, as well as experience with MS Excel, MS PowerPoint, and MS Project or Smartsheet. Self-starter, with strong track record of working both independently and in collaboration with program stakeholders. High attention to detail and ability to work on multiple projects with tight deadlines. Strong project management and organizational skills, with demonstrated ability to absorb new technical/strategic information and be flexible to adapt accordingly. Working Conditions and Physical Requirements Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels. Compensation The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location. Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package. The anticipated salary range for this role is $160,000 - $178,000. The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time. Equal Employment Opportunity Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees. Privacy Notice To learn about how Fate collects and uses job application information, please visit Fate's online Privacy Notice. About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. Recruitment Fraud Alert Recently, we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo, as well as employee names and job titles, to gain a job seeker’s personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams. Here are a few things to be aware of to help identify recruitment fraud: - Our Talent Acquisition team only corresponds from our @fatetherapeutics.com domain. - At no stage in our hiring process will we require payment or ask you to make deposits in your bank account. - We will only ask for personal information when applying for a position via our Careers page or thereafter. - At no stage during our hiring process will we ask you to click a link to begin a one-way video interview. - We do not use Google Hangouts, WhatsApp, or other third-party messaging platforms to recruit candidates or conduct interviews. Please exercise caution. If something feels off about your interactions, we encourage you to contact us at [email protected] to confirm the authenticity of the message. Your security is important to us, and we appreciate your vigilance. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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2 weeks ago

CNC Shift Supervisor

Western CNC - Vista, CA 92081

*Job Summary* Busy North County San Diego CNC Machine Shop looking for a CNC Shift Supervisor. The CNC Shift Supervisor is responsible for overseeing the day-to-day operations of the designated work shift, managing staff performance, assigning tasks, ensuring smooth operations, resolving issues that arise during the shift, and maintaining adherence to company policies, all while prioritizing customer satisfaction and efficient productivity within their assigned timeframe. 5+ years CNC Machining experience required *Responsibilities* *Staff Management:* · Scheduling and assigning tasks to team members according to workload and priorities. · Training new employees. · Monitoring employee performance and providing feedback and coaching. · Addressing employee concerns and resolving conflicts with the oversite of Upper Management and the Human Resources Department. · Conducting performance evaluations and providing training as needed. · Meeting/collaboration with other Shift Supervisors from 1st, 2nd or 3rd and Management on a daily basis to ensure smooth transition between shift operations is accomplished. *Operational Oversight:* · Ensuring compliance with all company policies and procedures during the shift. · Managing opening and closing procedures as required. · Identifying and resolving operational issues that arise during the shift. *Communication and Reporting:* · Communicating shift updates and important information to other supervisors and staff members. · Maintaining accurate shift logs and reporting on key performance metrics. · Collaborating with other departments to ensure smooth operations. Monday through Friday Overtime as required daily and weekends Job Type: Full-time Pay: $33.00 - $56.42 per hour Benefits: * 401(k) * 401(k) matching * Dental insurance * Health insurance * Paid time off * Vision insurance Work Location: In person

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2 weeks ago

Manufacturing Assembler B

L3Harris - San Diego, CA 92121

L3Harris is dedicated to recruiting and developing high-performing talent who are passionate about what they do. Our employees are unified in a shared dedication to our customers’ mission and quest for professional growth. L3Harris provides an inclusive, engaging environment designed to empower employees and promote work-life success. Fundamental to our culture is an unwavering focus on values, dedication to our communities, and commitment to excellence in everything we do. L3Harris Technologies is the Trusted Disruptor in the defense industry. With customers’ mission-critical needs always in mind, our employees deliver end-to-end technology solutions connecting the space, air, land, sea and cyber domains in the interest of national security. Job Title: Manufacturing Assembler Job Code: 30420 Job Location: San Diego, CA Job Schedule: 9/80 Job Description: Assemble hardware of Space/Intel products using soldering iron, work under Microscope, hotplate, crimping tools, torque drivers. Position requires the ability to work in a dynamic and fast-paced environment with a focus on quality and attention to detail. Essential Functions: Ability to read assembly drawings, BOM, wire list, engineering change orders, rework instructions, and process control instructions Fully proficient individual contributor. Works under limited supervision. May be a resource to other employees in areas of expertise. Assignments are moderately difficult requiring some judgment Able to work under Microscope Tinning of components using solder pot Hand soldering of SMT, through-hole, fine pitch components, and wiring General clean up, epoxy, and conformal coating Mechanical assembly using torque drivers. Good communication skills, both oral and written High level of accuracy and strong attention to detail Plan and execute work schedules in conjunction with hardware schedule requirements Responsible for the manufacturing of all hardware on one or more product lines. Minimum of 4 years of SMT and Through Hole solder experience Familiar with wiring, harness assembly, and coax cable assembly Preference will be given to candidates who are certified in J-STD-001 Class 3 Qualifications Requires a High School Diploma or equivalent and a minimum of 4 years of prior relevant experience or 2 years post-Secondary/Associates Degree with 0 to 2 years of prior related experience. Preferred Additional Skills: Ability to read documentation, drawings, and process control instructions. Experience soldering skills. Familiarity with basic computing environments (Windows) In compliance with pay transparency requirements, the salary range for this role in California is $18.50/hr- $34.37/hr. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. L3Harris also offers a variety of benefits, including health and disability insurance, 401(k) match, flexible spending accounts, EAP, education assistance, parental leave, paid time off, and company-paid holidays. The specific programs and options available to an employee may vary depending on date of hire, schedule type, and the applicability of collective bargaining agreements. #LI-DK2 L3Harris Technologies is proud to be an Equal Opportunity Employer. L3Harris is committed to treating all employees and applicants for employment with respect and dignity and maintaining a workplace that is free from unlawful discrimination. All applicants will be considered for employment without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender (including pregnancy, childbirth, breastfeeding or other related medical conditions), gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, characteristic or membership in any other group protected by federal, state or local laws. L3Harris maintains a drug-free workplace and performs pre-employment substance abuse testing and background checks, where permitted by law. Please be aware many of our positions require the ability to obtain a security clearance. Security clearances may only be granted to U.S. citizens. In addition, applicants who accept a conditional offer of employment may be subject to government security investigation(s) and must meet eligibility requirements for access to classified information. By submitting your resume for this position, you understand and agree that L3Harris Technologies may share your resume, as well as any other related personal information or documentation you provide, with its subsidiaries and affiliated companies for the purpose of considering you for other available positions. L3Harris Technologies is an E-Verify Employer. Please click here for the E-Verify Poster in English or Spanish. For information regarding your Right To Work, please click here for English or Spanish.

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2 weeks ago

Cable Tester

Moore & Associates - San Diego, CA 92127

Leading designer and manufacturer of innovative interconnect products and complex cable assemblies has an immediate opening for a Tester with Soldering skills. Duties/Responsibilities: * Checks Customer Specification Sheet (CSS) to determine required assembly, exterior finish on product, and any special options. * Uses various machines and hand tools to accomplish assigned tasks. * Maintains logs, records, and reports concerning production, machine maintenance, and product inconsistencies. * May do one or more of these functions: solder; assembly of components into sets or sub-assemblies; crimping; electrical testing; pull-testing; stripping machines; * Perform functional testing to ensure assembled products meet quality standards * Reports other problems to line supervisor or quality control inspector for assistance. * Reporting of quantity and in process inspection on traveler as required. * Solder components with precision and care following safety procedures. * Safely lift and carry materials and finished products weighing up to 50 lbs. * Maintains clean and safe working environment in line with company policies. * Follow all safety protocols and company policies. * Performs other related duties as assigned. Required Skills/Abilities: * Detail-oriented and consistent. * Previous experience in assembly, soldering and testing. * Ability to use soldering equipment and testing tools effectively. * Works well as a productive member of a team. * Experience in intricate hand assembly on paced assembly line depending on whether entry-level or more senior assembly position. * Knowledge of hand and automated tools; soldering irons and soldering tools; * Use of electrical meters; pc based automated electrical test equipment and high potential low amperage equipment, hand presses. Education and Experience: * High school diploma or equivalent required. Physical Requirements: * Prolonged periods standing and performing repetitive tasks. * Must be able to lift up to 50 pounds at a time. * Must have manual dexterity in order to assemble products or machines as directed. * Must have excellent hand-eye coordination. * Ability to differentiate between colored wires, tabs, and electronic components. Job Type: Full-time Pay: $21.00 - $23.00 per hour Benefits: * Health insurance Work Location: In person

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2 weeks ago

QC Inspector – 1st & 2nd Shift

Moore & Associates - San Diego, CA 92128

Outstanding medical device components manufacturer has immediate openings for Quality Inspectors to join their team! JOB PURPOSE The Quality Inspector monitors the quality of incoming, in process, and outgoing products or materials for Company. They are tasked with conducting tests, performing measurements, and auditing production processes. PRINCIPAL ACCOUNTABILITIES Able to utilize microscope, digital calipers, micrometer, optical comparator, vision measurement system, and other related equipment with optimal accuracy Proficient understanding and working knowledge of blueprints and GD&T *Inspection* * In-process * First article * Receiving * Final Maintain proper inspection and test records Able to train other employees as needed within department and production departments Perform daily scale verification Perform monthly vision system verification Ordering inspection supplies, ex. Pin gages, consumables Assures that non-conforming material has been properly identified Advises the responsible production personnel of acceptability of products or materials based on results of testing and/or inspection Maintains lot traceability, log sheets, and good housekeeping practices at all times Maintains a working knowledge of safety policies and regulations to ensure duties of self and others are performed in a safe manner Proficient with computer applications ex. ERP system, document control systems, nonconforming product systems. Able to work overtime (including weekends) when needed QUALIFICATIONS/ KNOWLEDGE/ EXPERIENCE * High School diploma or equivalent Essential * 3 or more years manufacturing work experience with demonstrated ability in inspection * Must be able to utilize all hand tools, micrometers, optical comparator, and other related * equipment with optimal accuracy. * Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables Schedules available: 1st shift: 6:00 am - 2:30 pm (1 opening) 2nd shift: 2:00 pm - 10:30 pm (will train on 1st shift for approx 1 month), + 10% paid shift differential. (1 opening) Please submit your resume for consideration. Job Type: Full-time Pay: $22.00 - $25.00 per hour Benefits: * Health insurance Work Location: In person

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