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Process Validation Manufacturing Engineer Jobs in California

Danaher

Senior Engineer, Process Validation

Sunnyvale, CA · On-site +1

$100K - $130K/yr

The Senior Engineer, Process Validation is responsible for leading & supporting internal and ... Knowledge of global regulatory requirements and cGMP regulations for pharmaceutical manufacturing ...

Danaher

Senior Engineer, Process Validation

Sunnyvale, CA · On-site +1

$100K - $130K/yr

The Senior Engineer, Process Validation is responsible for leading & supporting internal and ... Knowledge of global regulatory requirements and cGMP regulations for pharmaceutical manufacturing ...

Actalent

Manufacturing Engineer

Ventura, CA

$78K - $100K/yr

Manufacturing Engineer The Manufacturing Engineer provides hands-on engineering support to manufacturing operations by troubleshooting equipment, improving processes, executing validation activities ...

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Process Validation Manufacturing Engineer information

What is the difference between Process Validation Manufacturing Engineer vs Quality Control Analyst?

AspectProcess Validation Manufacturing EngineerQuality Control Analyst
Required CredentialsBachelor's in Engineering, Life Sciences, or related field; certifications like ASQ CQE or CSQEBachelor's in Chemistry, Biology, or related field; certifications like ASQ CQPA
Work EnvironmentManufacturing facilities, validation labs, production linesLaboratories, quality testing environments, production support
Employer & Industry UsagePharmaceutical, biotech, medical device manufacturingPharmaceutical, biotech, medical device industries

The Process Validation Manufacturing Engineer focuses on developing and executing validation protocols to ensure manufacturing processes meet quality standards. In contrast, the Quality Control Analyst primarily conducts testing and inspections to verify product quality. Both roles are essential in regulated industries like pharmaceuticals and biotech, often working together to ensure compliance and product safety.

What cities in California are hiring for Process Validation Manufacturing Engineer jobs?

Cities in California with the most Process Validation Manufacturing Engineer job openings:

Infographic showing various Process Validation Manufacturing Engineer job openings in California as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 16% Part Time, 4% Contract, and 1% Nights. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.

Manufacturing Engineer - Medical Device (Process

Irvine, CA • On-site

Stark Pharma Solutions Inc
See more jobs at Stark Pharma Solutions Incexternal

$78K - $105K/yr

Contractor

Posted 9 days ago

Job description

ABOUT COMPANY:

Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.

Manufacturing Engineer – Medical Device (Process Validation, NPI, Lean)

JOB SUMMARY:

Our client, a medical device manufacturer, is seeking a Manufacturing Engineer to support production operations and process improvement on the manufacturing floor. The role covers process validation, tooling and fixture support, new product introduction and day-to-day troubleshooting in an ISO 13485 environment.

RESPONSIBILITIES:

  • Support daily production operations and troubleshoot process and equipment issues on the manufacturing floor
  • Execute process validation activities (IQ/OQ/PQ) for manufacturing equipment and processes
  • Drive process improvement initiatives to improve yield and reduce scrap and cycle time
  • Design and qualify tooling and fixtures to support production
  • Develop and update work instructions, routers and manufacturing documentation
  • Support new product introduction (NPI) and transfer to manufacturing
  • Process engineering change orders (ECO/ECN) and assess manufacturing impact
  • Support non-conformance and CAPA investigations related to manufacturing processes

QUALIFICATIONS:

  • Bachelor's degree in Mechanical, Industrial, Biomedical or Manufacturing Engineering
  • 3–5 years of manufacturing engineering experience in medical device
  • Experience with process validation (IQ/OQ/PQ)
  • Working knowledge of ISO 13485 and 21 CFR Part 820
  • CAD experience, SolidWorks preferred, and working knowledge of GD&T
  • Lean Manufacturing and Six Sigma exposure
  • Must be legally authorized to work in the United States
  • W2 employment only

HOW TO APPLY:

Please send your resume to deepika.b@starkpharma.com. In your email, please include your current location, your hourly rate expectation on W2, and your availability to start.