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
- ...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...SuggestedContract workRemote work
- ...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
- ...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...SeniorWorldwide
$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...SeniorTemporary workFor contractorsWork at officeWork visaFlexible hours- 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...SeniorHourly pay
- ...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 timeWork at officeShift work
- ...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...
- ...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...
$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....SeniorFor contractors$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...SeniorNight shift$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...SeniorTemporary workFlexible hours- ...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...SeniorHourly payShift work
$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...SeniorTemporary workFor contractorsWork at officeWork visaFlexible hours$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...SeniorWork at office- ...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
- ...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...SeniorWork at officeLocal areaImmediate startFlexible hours2 days per week
- 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...SeniorWork at officeLocal areaFlexible hours2 days per week
$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$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 payFull timeTemporary workWorldwideFlexible hours- ...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...SeniorContract workRelocation
$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 timeWork at officeRemote workWorldwideShift work- ...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...SeniorWork experience placementWork at officeLocal area
$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...SeniorWork at office$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- 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 workLocal area
$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,...SeniorLocal areaRelocationShift work$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$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- 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...SeniorRemote work
$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...SeniorFull timeContract workWork at office
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