Senior Validation Engineer
Not Disclosed•Full-TimeOn-site
location_on70, Sherwood Lane, Raynham Center, Raynham, Bristol County, Massachusetts, 02767, United States
About the Role
Insight Global is seeking a Senior Validation Engineer to support a top-tier medical device client during a critical separation activity. In this high-impact role, you will ensure all software-driven manufacturing systems meet rigorous regulatory and quality standards. The position focuses heavily on validating HMI programs, executing validation protocols, and partnering cross-functionally to guarantee a smooth transition. This opportunity is ideal for professionals who thrive in fast-paced, regulated environments and possess the experience necessary to navigate complex validation projects within large-scale divestitures or carve-outs.
Work location
Work model: On-site
70, Sherwood Lane, Raynham Center, Raynham, Bristol County, Massachusetts, 02767, United States
Raynham, Massachusetts
Key Responsibilities
- check_circleSupport separation activities during large-scale transitions or divestitures
- check_circleExecute validation protocols for software-driven manufacturing systems
- check_circleCollaborate cross-functionally to ensure smooth system transitions
- check_circleDevelop and maintain system documentation including IQ, OQ, and PQ
- check_circleEnsure all manufacturing systems meet FDA, ISO, and GxP regulations
- check_circleValidate HMI programs to ensure compliance with regulatory standards
Requirements
- verifiedSenior-level validation engineering experience in a regulated environment
- verifiedStrong background in software validation
- verifiedHands-on experience validating HMI programs
- verifiedExperience working under FDA / ISO / GxP regulations
- verifiedKnowledge of CSV (Computer System Validation) methodologies
- verifiedExperience supporting system documentation (IQ, OQ, PQ)
- verifiedExperience in medical device manufacturing
- verifiedFamiliarity with manufacturing execution systems (MES)
- verifiedExperience with equipment/software tied to automated manufacturing lines
Nice to Have
Prior Johnson & Johnson, DePuy Synthes, or large enterprise separation experience. Familiarity with manufacturing execution systems (MES). Experience with equipment/software tied to automated manufacturing lines. Previous involvement in company divestitures or carve-outs.
Benefits & Perks
check_circle401(k) retirement plan eligibility begins after 90 days of employmentcheck_circlePaid sick leave and other paid time off benefits as required by applicable law
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Frequently asked questions about Senior Validation Engineer at Insight Global
What does a Senior Validation Engineer at Insight Global do?expand_more
Day-to-day, the Senior Validation Engineer at Insight Global will support separation activities during large-scale transitions or divestitures; execute validation protocols for software-driven manufacturing systems; collaborate cross-functionally to ensure smooth system transitions; and develop and maintain system documentation including iq, oq, and pq.
What are the requirements for this Senior Validation Engineer role?expand_more
To qualify for the Senior Validation Engineer at Insight Global position, applicants should have: Senior-level validation engineering experience in a regulated environment; Strong background in software validation; Hands-on experience validating HMI programs; Experience working under FDA / ISO / GxP regulations; Knowledge of CSV (Computer System Validation) methodologies; and Experience supporting system documentation (IQ, OQ, PQ).
Where is the Senior Validation Engineer role at Insight Global located?expand_more
Senior Validation Engineer at Insight Global is based in 70, Sherwood Lane, Raynham Center, Raynham, Bristol County, Massachusetts, 02767, United States. This is a on-site role.
Is this Senior Validation Engineer job remote, hybrid, or on-site?expand_more
Insight Global has listed this Senior Validation Engineer role as on-site.
How much experience is required for this Senior Validation Engineer role?expand_more
Candidates for Senior Validation Engineer at Insight Global should have senior.
What skills do you need for the Senior Validation Engineer role at Insight Global?expand_more
Key skills for Senior Validation Engineer at Insight Global include Hmi Programs; CSV; Computer System Validation; Iq; Oq; PQ; Mes; and Manufacturing Execution Systems.
What category does the Senior Validation Engineer role belong to?expand_more
Senior Validation Engineer at Insight Global is part of the engineering job category on Recrutus.