Senior Csv / Lab Instrument Validation Consultant Category Biotech/pharmaceutical Location Foster City, Ca

AdeptSource

Foster City, CA
Doe
On-site
Lab instrument qualification
Standalone lab instrument software systems
Gmp and regulatory requirements
AdeptSource is seeking a Senior CSV / Lab Instrument Validation Consultant to oversee validation efforts for laboratory software systems in a pharmaceutical environment. The role requires extensive experience in lab instrument qualification, regulatory compliance, and strong analytical skills. The position is contract-based, located in the South San Francisco Bay Area, with remote work options during COVID

Job Summary

  • Responsible for planning, leading, and executing validation efforts for standalone Lab Instrument Software systems.
  • Must have hands-on experience in Lab Instrument Qualification within a Pharmaceutical environment.
  • Experience must come from a pharmaceutical, biotech industry with direct knowledge of FDA regulations including 21CFR Part 11.

Matching Summary

Match Score: 85

AdeptSource is seeking a Senior CSV / Lab Instrument Validation Consultant to oversee validation efforts for laboratory software systems in a pharmaceutical environment. The role requires extensive experience in lab instrument qualification, regulatory compliance, and strong analytical skills. The position is contract-based, located in the South San Francisco Bay Area, with remote work options during COVID.

Salary

DOE

Skills & Requirements

Must-have

  • Lab Instrument Qualification
  • Standalone Lab Instrument Software systems
  • GMP and regulatory requirements
  • Instrument lifecycle mapping
  • Validation plans and data analysis
  • FDA guidelines for Instrument and Software validation
  • 21 CFR Part 11

Nice-to-have

  • Guidance to management on improvements
  • Troubleshooting and problem-solving
  • Cross-functional project team participation
  • Self-motivated and detail-oriented

Key Requirements

  • Hands-on experience in Lab Instrument Qualification
  • Experience in pharmaceutical or biotech industry
  • Direct knowledge of FDA regulations including 21CFR Part 11

Work Rights

Not specified

Tailored Resume

Cover Letter