Senior Computer Systems Validation Engineer
DeWinter BH ·www.dewintergroup.com
Apply direct
Title: Validation Engineer / Business Systems Analyst
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:
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.
Frequently asked questions
Who is hiring for the Senior Computer Systems Validation Engineer role?
DeWinter BH is hiring for the Senior Computer Systems Validation Engineer position, a Shazamme client. Apply directly on the employer's career site.
Where is the Senior Computer Systems Validation Engineer job located?
The Senior Computer Systems Validation Engineer role with DeWinter BH is based in San Carlos, US. The role is hybrid-friendly.
Is the Senior Computer Systems Validation Engineer role remote?
Yes — the Senior Computer Systems Validation Engineer position at DeWinter BH is hybrid. Candidates based in US are preferred.
Is the Senior Computer Systems Validation Engineer role full-time or contract?
This is a full time position at DeWinter BH.
What experience level is the Senior Computer Systems Validation Engineer role?
The Senior Computer Systems Validation Engineer position is aimed at senior-level candidates.
How do I apply for the Senior Computer Systems Validation Engineer role at DeWinter BH?
Apply directly on DeWinter BH's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.