Sr. CSV / Lab Instrument Validation Specialist
Type of role:
Hourly pay rate:
DOE (C2C, W2, or 1099 permissible)
South San Francisco Bay Area
Our customer is seeking a Senior CSV / Lab Instrument Validation Engineer who is well versed in laboratory Instrument / Equipment processes within a Pharmaceutical environment. Must have
hands experience on Instrument Qualification. Should have no less than 7 years of CSV.
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 standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
- Responsible for the mapping and bringing consistency to the instrument lifecycle globally, from supporting purchase to instrument validation to decommissioning documentation.
- Plan, lead, and execute the standardizing of 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.