Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Senior Validation Engineer — 21 CFR, GAMP5, IQ/OQ/PQ

Pharma Tek Solutions

No of Positions: Multiple Location: San Ramon, CA and various unanticipated locations throughout the U.S. Job Description: Design, develop and oversee validation components and ensure compliance with 21 CFR Part 11, and Part 8, and GAMP5 regulations. Author and review Validation plan and Validation Summary reports. Track and manage defects and change controls using HP Quality Center, ALM and similar tools. Write and execute IQ/OQ/PQ scripts for functional, system, and regression testing. Performing Periodic and Audit Trail reviews. Qualification: Master’s degree in Science, Technology, or Engineering (any) is required. If interested, please send resume to HR Dept., Pharma Tek Solutions, Inc., 6101 Bollinger Canyon Road, Suite 336, San Ramon, CA 94583. #J-18808-Ljbffr Pharma Tek Solutions

Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Senior Validation Engineer — 21 CFR, GAMP5, IQ/OQ/PQ in San Ramon, CA vacancy
  •  ...Solutions team is seeking a Manufacturing Engineer to join our highly valued client. The...  ...related issues. Develop and execute IQ/OQ/PQ validation protocols, analyze validation data,...  ...). ~ Working knowledge of ISO 13485, 21 CFR Part 820, and statistical methodologies... 
    Suggested
    Contract work
    Remote work

    Stevenson Search Partners

    Hayward, CA
    4 days ago
  •  ...Introduction - NPI) ~ Good experience in process development & process characterization ~ Good experience in Process Validations - IQ, OQ, PQ ~ Experience in test fixture design ~ Experience in PFMEA ~ Good knowledge in Statistical analysis using... 
    Senior

    Yochana

    Pleasanton, CA
    2 days ago
  •  ...Sr. Automation Engineer (Laboratory) Predicine is a Silicon Valley-based global precision medicine company that is committed to developing...  ...Maintain and manage instrument configuration documentation (IQ/OQ/PQ and SOP). Complete quality documentation reports and ensure... 
    Senior
    Worldwide

    Predicine Inc

    Hayward, CA
    1 day ago
  • $96k - $132k

     ...Senior Manufacturing Engineer This is where your work makes a difference. At Baxter, we believe...  ...process improvements to support process validation and contribute to maximizing...  ...improvements, supporting process validation (IQ/OQ/PQ), PFMEA, and overall product... 
    Senior
    Temporary work
    For contractors
    Work at office
    Work visa
    Flexible hours

    Baxter

    Hayward, CA
    4 days ago
  • Summary The Senior R&D Technician is a critical member of...  ...Working closely with R&D, engineering, and manufacturing teams,...  ...performance. Assist in validation activities including IQ/OQ/PQ and design verification testing...  ...(e.g., ISO 13485, FDA 21 CFR Part 820). Who You Will... 
    Senior
    Hourly pay

    Calyxo, Inc.

    Pleasanton, CA
    4 days ago
  •  ...Manufacturing Engineer – Capital - Pleasanton, CA Calyxo, Inc. is a medical device company...  ...also contributes to documentation, validation, equipment support, and continuous improvement...  ...of process and equipment validations (IQ/OQ/PQ). Coordinate with external vendors as... 
    Full time
    Work at office
    Shift work

    Calyxo USA Inc

    Pleasanton, CA
    3 days ago
  •  ...Job Summary: Manufacturing Engineer with 3-4 years of experience in the medical device manufacturing industry, specializing...  .... Experienced in manufacturing operations, process validation (IQ/OQ/PQ), configuration management, and continuous process improvement... 

    Katalyst Healthcares and Life Sciences

    Dublin, CA
    2 days ago
  •  ...working with PTC Windchill and any MES system ~ Basic Experience in process development, process characterization, Process Validation - IQ, OQ, PQ ~ Experience in PFMEA ~ Knowledge in Statistical analysis using Minitab ~ Good communication skills... 

    Omni Inclusive

    Pleasanton, CA
    1 day ago
  • $120k - $150k

     ...Commissioning, Qualification & Validation – Pharmaceutical...  .... MMR Consulting is an engineering and consulting firm specializing...  ...of: FAT/SAT protocols IQ/OQ/PQ protocols Validation documentation...  ...and KPI reporting to senior leadership and stakeholders.... 
    Senior
    For contractors

    MMR Consulting

    Hayward, CA
    12 hours ago
  • $114k

     ...overall public and employee safety. Validates whether employees are...  ...Code of Federal Regulations (CFR) 49.192 (N) and 49.192 (E). PG...  ...the operation qualification (OQ) process Fully understands and...  ...Desired: Bachelors Degree in Engineering or job-related discipline or equivalent... 
    Senior
    Night shift

    Pacific Gas and Electric Company

    San Ramon, CA
    4 days ago
  • $107.72k - $161k

    The Senior Facilities Engineer is responsible for ensuring the smooth operation of manufacturing facilities...  ...Assist in the execution of equipment IQ/OQ/PQ in GMP manufacturing. Support and...  ...maintenance, repairs, IOPQ, validation, and other equipment lifecycle processes... 
    Senior
    Temporary work
    Flexible hours

    Otsuka Pharmaceutical Co., Ltd

    Hayward, CA
    2 days ago
  •  ...atmosphere. Summary: The Senior R&D Technician is a...  ...Working closely with R&D, engineering, and manufacturing teams,...  .... Assist in validation activities including IQ/OQ/PQ and design verification testing...  ...systems (e.g., ISO 13485, FDA 21 CFR Part 820). Who You... 
    Senior
    Hourly pay
    Shift work

    Calyxo

    Pleasanton, CA
    9 days ago
  • $96k - $132k

     ...and pride.  Your Role The Senior Manufacturing Engineer is a key site operations representative...  ...improvements to support process validation and contribute to maximizing production...  ..., supporting process validation (IQ/OQ/PQ), PFMEA, and overall product assembly... 
    Senior
    Temporary work
    For contractors
    Work at office
    Work visa
    Flexible hours

    Baxter International Inc

    Hayward, CA
    10 days ago
  • $120k - $160k

    Barry-Wehmiller Companies Inc. is seeking a Senior Process Engineer to support process system engineering in pharmaceutical, biologics, and medical device manufacturing. This senior-level role ensures the design, execution, and optimization of crucial engineering processes... 
    Senior
    Work at office

    Barry-Wehmiller Companies Inc.

    San Ramon, CA
    12 hours ago
  •  ...Description: JOB SUMMARY The Manufacturing Engineer L1 is a key member of the manufacturing...  ...customer complaints, and RMAs; develop, validate, and implement corrective and preventive...  ...design, and equipment qualification (IQ/OQ/PQ). • Collect, analyze, and interpret... 
    Internship

    DELPHON INDUSTRIES LLC

    Hayward, CA
    2 days ago
  •  ...work we do possible. Sr. Principal Architect - Platform Engineering-Hybrid San Ramon, CA We are seeking an exceptional Sr...  ...extensions, migrations, integrations, and new capabilities Mentor senior engineers and contribute to raising architectural maturity... 
    Senior
    Work at office
    Local area
    Immediate start
    Flexible hours
    2 days per week

    PTC

    San Ramon, CA
    2 days ago
  • Sr. Principal Architect - Platform Engineering (Hybrid, San Ramon, CA) We are seeking an exceptional Sr Principal Architect - Platform Engineering...  ..., migrations, integrations, and new capabilities. Mentor senior engineers and contribute to raising architectural maturity... 
    Senior
    Work at office
    Local area
    Flexible hours
    2 days per week

    PTC Inc.

    San Ramon, CA
    3 days ago
  • $130k - $160k

    A leading engineering firm is seeking a Senior Controls Engineer in San Ramon, CA. The ideal candidate should have over seven years of experience in automation, including HMI and PLC programming in the packaging industry. You'll join a committed team, work on critical... 
    Senior

    Barry-Wehmiller Companies Inc.

    San Ramon, CA
    3 days ago
  • $96k - $174k

     ...residential, industrial, and utility applications. To fuel this mission, Tesla Energy's Compliance team seeks a passionate Product Validation Engineer with deep expertise in system integration and validation. You'll ensure seamless hardware-firmware performance across our... 
    Hourly pay
    Full time
    Temporary work
    Worldwide
    Flexible hours

    Tesla

    Hayward, CA
    4 days ago
  •  ...faster with portable factories YouTube – full video of our Gen1 robots building a solar farm About This Role As a Senior Manufacturing Engineer at Charge Robotics and the first in our manufacturing function, you'll work closely with both internal teams and... 
    Senior
    Contract work
    Relocation

    Charge Robotics

    San Leandro, CA
    1 day ago
  • $100k

     ...Manufacturing Test Engineer Location: Benicia, CA Job Type: Full time Requisition ID: JR100065 RIX Industries is a...  ...cause analysis, and implementing corrective actions. Lead the validation, integration, commissioning, and continuous improvement of new... 
    Full time
    Work at office
    Remote work
    Worldwide
    Shift work

    RIX Industries

    San Ramon, CA
    4 days ago
  •  ...Summary The Senior Regulatory Affairs Specialist supports and executes regulatory activities...  ...in Regulatory Affairs, Biomedical Engineering, Life Sciences, Engineering, or related...  ...& Skills Strong knowledge of 21 CFR Parts 800-820, ISO 13485, ISO 14971, EU... 
    Senior
    Work experience placement
    Work at office
    Local area

    ProSomnus Sleep Technologies

    Pleasanton, CA
    3 days ago
  • $120k - $160k

    Job Overview Senior Process Engineer - a senior-level role focused on process system engineering and design across pharmaceutical, biologics, and medical device manufacturing. The position supports capital projects, greenfield construction, and process optimization for... 
    Senior
    Work at office

    Barry-Wehmiller Companies Inc.

    San Ramon, CA
    1 day ago
  • $96k - $132k

    Zvh is seeking a Senior Manufacturing Engineer to support site operations in Hayward, California. Responsibilities include driving production improvements and ensuring compliance with safety regulations. Candidates should have a Bachelor's degree in Engineering and relevant... 
    Senior

    Zvh

    Hayward, CA
    12 hours ago
  • Global Technical Talent, an Inc. 5000 Company, is seeking a Contract Specialist in San Ramon, CA. This hybrid position involves validating vendor invoices and requires expertise in Vendor Master Services Agreements and Salesforce. The ideal candidate has 4+ years in contract... 
    Contract work
    Local area

    Global Technical Talent, an Inc. 5000 Company

    San Ramon, CA
    2 days ago
  • $128.2k - $192.4k

     ...progress is made. We're entering an exciting growth phase, scaling production across the U.S. and Europe and expanding our team of engineers, scientists, and innovators. Apply now to join our team and be part of something bigger than yourself - where collaboration,... 
    Senior
    Local area
    Relocation
    Shift work

    Lyten

    San Leandro, CA
    12 hours ago
  • $105k - $220k

    1X Technologies AS is seeking a Senior Manufacturing Engineer to oversee the Hands production area. This role involves optimizing assembly processes for humanoid robots, ensuring quality and scalability. The ideal candidate will have a Bachelor's degree in Mechanical Engineering... 
    Senior

    1X Technologies AS

    Hayward, CA
    3 days ago
  • $170k - $209k

    Zoox is seeking an Issue Resolution Engineer to ensure the quality and readiness of autonomous vehicles during manufacturing in Hayward, California. This role requires leading efforts in issue containment, cross-functional collaboration, and implementing corrective actions... 
    Senior

    Zoox

    Hayward, CA
    12 hours ago
  • HR Tech Job is seeking a Sr. Principal Technical Program Manager to lead complex M&A integrations. This role requires a strong track record in program management, with at least 12 years of experience and a focus on cross-functional initiatives. As part of the Business Technology...
    Senior
    Remote work

    HR Tech Job

    Pleasanton, CA
    2 days ago
  • $125k - $145k

    Sr. Manufacturing Test Engineer Location: Pleasanton, CA About the Role We are seeking a hands-on Sr. Manufacturing Test Engineer to...  ...processes for our LiDAR systems and subassemblies. • Set up, validate, maintain, and improve production test stations, fixtures, and... 
    Senior
    Full time
    Contract work
    Work at office

    AEye, Inc

    Pleasanton, CA
    12 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Validation Engineer — 21 CFR, GAMP5, IQ/OQ/PQ. Be the first to apply!