Title: CSV / Lab Instrument Validation Specialist
Type of role: Contract
Duration: 12-24+ months
Hourly pay rate: DOE (C2C, W2, or 1099 permissible)
Location: San Francisco Bay Area
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Our customer is seeking a CSV / Lab Instrument Validation Engineer who is well versed in laboratory Instrument/Equipment processes within a Pharmaceutical or Biotech environment. Must have hands experience on Instrument Qualification and very well familiar with Risk Based approach (USP-1058 and/or GAMP approach). Candidate must be aware of validation lifecycle and related deliverables including risk management. You will be responsible for planing, leading, and executing the validation efforts for standalone Lab Instrument Software systems.
Must have strong experience within the following:
- Responsible for performing validation of Laboratory Instrumentation by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
- Responsible for the entire instrument lifecycle from supporting purchase to instrument validation to decommissioning documentation.
- Plan, lead, and execute the validation efforts for standalone Lab Instrument Software systems.
- Responsible for developing and executing 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.
- Well versed in Laboratory Instrument process, ability to provide guidance to management on what improvements need to be made. (Essential for this role)
- May also investigate and trouble-shoot problems which occur, and determine solutions.
- Support change management and manage existing lab systems.
- Participates on cross-functional project teams with the support of Development, Quality, and other groups
- 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.
- Self-motivated, good communication, technical writing, presentation skills, detail oriented, analytical, and a team player.