Job Details

Sr. CSV / Lab Instrument Validation Specialist

Type of role: Contract

Duration: 12-36+ months

Hourly pay rate: DOE (C2C, W2, or 1099 permissible)

Location: South San Francisco Bay Area (Remote during COVID)

Our customer is seeking a Senior CSV / Lab Instrument Validation Engineer who is well versed in laboratory instrument processes within a pharmaceutical environment. Must have hands-on experience with Lab Instrument Qualification. You will be primarily responsible for planning, leading, and executing validation efforts for standalone Lab Instrument Software systems.

Must have strong experience in the following:

• Responsible for performing validation of laboratory instrumentation by following approved SOPs, GMPs, and all regulatory requirements.
• Responsible for mapping and bringing consistency to the instrument lifecycle globally, from purchase support to validation and decommissioning documentation.
• Plan, lead, and execute validation efforts for standalone Lab Instrument Software systems.
• Develop and execute validation plans according to approved procedures, collate test results, organize data packages, and maintain all validation documentation.
• Compile and analyze validation data, prepare reports, and recommend improvements.
• Provide guidance on laboratory instrument processes and suggest improvements to management.
• Investigate and troubleshoot issues, determining effective solutions.
• Support change management and manage existing lab systems.
• Participate in cross-functional project teams with Development, Quality, and other groups.
• Familiar with FDA guidelines for instrument and software validation.
• Experience in the pharmaceutical or biotech industry with knowledge of FDA regulations, including 21 CFR Part 11.
• Self-motivated with good communication, technical writing, presentation skills; detail-oriented, analytical, and a team player.