More jobs:
CSV Engineer
Job in
Minneapolis, Hennepin County, Minnesota, 55400, USA
Listed on 2026-02-17
Listing for:
GxP Associates
Full Time
position Listed on 2026-02-17
Job specializations:
-
Engineering
Systems Engineer, Cybersecurity -
IT/Tech
Systems Engineer, Data Analyst, Cybersecurity
Job Description & How to Apply Below
We are currently hiring experienced professionals for the position of
CSV (Computer System Validation) Engineer
within the Pharmaceutical / Biotech / Medical Device industry. This is an onsite opportunity and we are considering
W2 candidates only (No C2C).
Experience: 4–10+ Years
Location: Onsite
Employment Type:W2 Only
Key Responsibilities:- Perform Computer System Validation (CSV) activities in compliance with FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 guidelines.
- Develop and review validation lifecycle documents including VMP, URS, FS, DS, IQ, OQ, PQ, RTM, and VSR.
- Execute validation protocols and manage deviations, CAPAs, and change controls.
- Conduct risk assessments and apply a risk-based validation approach.
- Ensure Data Integrity (ALCOA+) compliance across validated systems.
- Support regulatory inspections and audits (FDA, EMA, MHRA).
- Collaborate with IT, QA, Engineering, and cross-functional business teams.
- Validate both on-premise and cloud/SaaS systems.
Skills & Experience:
- Strong hands-on experience in Computer System Validation within regulated environments.
- In-depth knowledge of 21 CFR Part 11, Annex 11, and GAMP 5.
- Experience validating systems such as LIMS, MES, QMS, ERP (SAP), and DMS.
- Expertise in IQ/OQ/PQ execution and test script development.
- Solid understanding of audit trails, user access control, and backup & recovery processes.
- Experience handling Change Control, Deviations, and Periodic Reviews.
If you are interested and meet the above qualifications, please share your updated resume at your earliest convenience.
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