Senior CSV / Lab Instrument Validation Consultant
AdeptSourceCalifornia, United States
Posted April 30, 2021
Full Time
About the Company
AdeptSource is a global IT consulting partner that specializes in delivering high‑level, hard‑to‑find IT talent to meet clients’ staffing and project goals. Leveraging a proprietary recruiting process and a vast internal database, the company offers flexible solutions—full‑project delivery, contract, contract‑to‑hire, or permanent placements—while maintaining low overhead to pass savings on to clients. AdeptSource’s focus on technical expertise, rapid placement, and cost‑effective service differentiates it in the competitive staffing market. In addition to its commercial offerings, the firm supports social impact by sponsoring an abandoned child through Arms of Love International for every placement. AdeptSource’s culture of integrity and professionalism makes it an attractive partner for organizations seeking reliable, top‑tier IT professionals.
Job Description
Our customer is seeking a Senior CSV / Lab Instrument Validation Engineer who is well versed in laboratory Instrument processes within a Pharmaceutical environment.
Requirements
- Responsible for performing validation of Laboratory Instrumentation by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
- Plan, lead, and execute the standardizing of validation efforts for standalone Lab Instrument Software systems.
- Develop and execute on validation plans according to approved procedures, collation of test results, and organizes data packages and maintains all documentation pertaining to validation.
- Ability to compile and analyze validation data, prepare reports and makes recommendations for changes and/or improvements.
- Familiar with FDA guidelines for Instrument and Software validation.
- Experience must come from a pharmaceutical, biotech industry with direct knowledge of FDA regulations including 21CFR Part 11.
