Title: CSV / Lab Instrument Validation Specialist

Type of role: Contract / Covid remote
Duration: 12-24+ months
Hourly pay rate: DOE (C2C, W2, or 1099 permissible)
Location: South San Francisco Bay Area
LOCAL CANDIDATES PREFERRED

Our large pharma customer is seeking a CSV / Lab Instrument Validation Engineer who is well versed in Laboratory Instrumentation and Equipment processes within a Pharmaceutical or Biotech environment. Must have hands experience on Instrument Qualification and must be familiar with Risk Based approach (USP-1058 and/or GAMP approach). Candidate must be experienced in validation lifecycle and related deliverables including risk management. You will be responsible for planning, leading, and executing the validation efforts for standalone Lab Instrument Software systems.

*Prior experience with LabX is strongly preferred.*

Must have strong experience with the following:

Responsible for performing CSV and validation of Laboratory Instrumentation by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
Must have recent experience with Qualification of Analytical Laboratory Instrumentation including Standalone Computerized and Server-based Instrument Systems.
Experience with any of the following is a big plus: LabX system for Mettler Toledo (MT) UV-Visible Spectrophotometer, LabX system for pH Meters, LabX system for KF Titrators, LIMS, Citrix, Veeva Vault, SharePoint, Trackwise.
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 validation plans according to approved procedures, as well as collation of test results, organizing of data packages and maintaining all documentation pertaining to validation.
Ability to compile and analyze validation data, prepare reports and make recommendations for changes and/or improvements.
Well-versed in Laboratory Instrument process, with the ability to provide guidance to management on what improvements need to be made. (Essential for this role)
Will also investigate and trouble-shoot problems which occur, and determine solutions.
Will support change management and manage existing lab systems.
Will participate in cross-functional project teams with the support of Development, Quality, and other groups
Must be knowledgeable in FDA guidelines for Instrument and Software validation.
Experience must come from pharmaceutical or 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.

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