Validation Engineer

Role: Validation Engineer
Foster city, CA
6 Months contract

• Onsite availability for work required.
• Rate $98-100/hr (or less)
• Contract Term - 6 months with possibility for extension

This role is a Validation Engineer for the qualification of Analytical Laboratory Instrumentation including specifically focusing on Computerized Analytical Instruments. Preferred experience with Malvern Particle Size Analyzer (Mastersizer 3000 software) and Metrohm Autotitrator (OMNIS software).

• Provides support during instrument purchasing by assessing instrument software for compliance with 21 CRF Part 11, Annex 11, and data integrity requirement and the software's capability to meet the intended use.
• Develops required validation deliverables in collaboration with a cross-functional team including user/SME and QA to ensure consistency in validation project execution. Includes user requirements, risk assessments, operational procedures and work instructions, validation plan/change management records, IQ/OQ/PQ protocol authoring and execution, requirements traceability matrix, etc.
• Executes protocols and develops validation summary reports.
• Responsible for reviewing vendor executed protocols to ensure the instrument was appropriately qualified to meet its intended use and that all documentation is performed according to Gilead's requirements and expectations.
• Responsible for ensuring instrument systems are validated per their intended use and meet data integrity and data security requirements.
• Assesses, authors, implements, and closes change management requests related to qualification, relocation, requalification, upgrade, and decommissioning, and completes deliverables for Deviations/CAPAs related to GxP-regulated analytical instrument systems.
• As required, assists in preparation of regulatory submissions and presents validation documentation to regulatory authorities during routine internal and pre-approval inspections.

Additional Requirements:

• Must have a Bachelor's degree and 5+ years of experience in a relevant or related field.
• Experience with Pharmaceutical/Biotechnology clients is strongly recommended
• Other skills: Team player, customer-focused, critical thinking, and problem solving are crucial skills for this role.