Contract position (long term)
Location: Emeryville, CA or San Mateo, CA
Seeking candidates with Veeva QualityDocs, QMS, RIM and/or eTMF experience or alternately experience with EDMS, QMS, regulatory submission and/or clinical enterprise systems.
We need someone who can be located at either Emeryville or San Mateo ?office in SF Bay area
The Validation Engineer plans, implements, and maintains computerized system validation for our Client's business systems used to support GxP regulated activities. The engineer ensures these systems meet intended uses and comply with applicable regulations, current industry practices, and corporate procedures.
Essential Duties and Responsibilities:
- Gather and documents user requirements from business stakeholders to establish intended use of computerized systems.
- Collaborate with project stakeholders to author validation deliverables (e.g. IQ, Validation Plan, Test Plan, Test Scripts, etc.)
- Manage validation activities of cross functional teams to ensure validation effort is executed to plan and properly documented in the appropriate validation documents.
- Support resolution and documentation of protocol and test discrepancies.
- Ensure validated systems remain in compliance with applicable regulations and internal procedures as changes to the systems are made.
- Maintain computerized system validation documentation.
- Experience in GxP regulated industry
- A minimum of 6 years in direct hands-on experience validating GxP Computerized Systems
- Familiarity with GxP regulations and approaches to System Development Life Cycles (SDLC) and GAMP
- Experience validating Quality, Regulatory and/or Clinical systems a plus