Job Type: Full-time (Permanent)
Pay Range: $164,000 - $190,000
Location: Hybrid (3 days onsite per week in San Carlos, CA; Tuesdays required)
About the Opportunity:
We are partnering with a leader in the biotechnology/pharmaceutical space to find a hands-on Validation Engineer or Business Systems Analyst. This is a crucial role for a candidate who sits at the intersection of technical execution and systems knowledge. You will be responsible for the end-to-end authorship of validation deliverables for manufacturing data systems (LIMS, MES) or custom cloud applications. This role requires an individual who enjoys deep-dive, hands-on work—writing documentation from scratch rather than overseeing or approving the work of others.
Key Responsibilities:
- Hands-on Authorship: Independently author comprehensive validation deliverables, including User Requirements Specifications (URS), IQ/OQ/PQ protocols, test scripts, and traceability matrices.
- Technical Execution: Own the validation process from start to finish, ensuring deep technical alignment between system configuration and compliance requirements.
- Systems Focus: Work directly with manufacturing data systems (LIMS, MES) or custom cloud-based applications.
- Collaboration: Partner with cross-functional engineering and quality teams to ensure all protocols are technically accurate and effectively executed.
- Hands-On Authorship: 5 to 10 years of proven experience personally authoring validation deliverables. You must be comfortable writing documentation from scratch—not just reviewing or approving others' work.
- Systems Expertise: Demonstrated experience with complex manufacturing data systems (LIMS, MES) or custom cloud applications.
- Independence: Ability to work autonomously and drive validation efforts with minimal oversight.
- Onsite Presence: Ability to work hybrid onsite 3 days per week in San Carlos, CA (Tuesdays are a mandatory anchor day).
- Experience with GxP regulatory environments.
- Knowledge of GAMP 5, DevOps/CI/CD, or cloud platforms.
