Insight Global
Validation Engineer - Top Medical Device Company
Insight Global, Raynham, Massachusetts, us, 02767
Validation Engineer - Top Medical Device Company
Insight Global is hiring a Validation Engineer in Massachusetts to support their client. This position is based on‑site as the engineer will be required to interface with manufacturing equipment, medical device products, and cross‑functional partners.
Base pay range $35.00/hr - $45.00/hr
Responsibilities
Develop, write, review, maintain, and revise manufacturing documentation, i.e., Process Work Instructions, Manufacturing Specifications, Inspection Procedures to support product Manufacturing.
Support development and execution of manufacturing equipment qualifications (URS/FAT/SAT/IQ).
Support development and execution of process validations (OQ/PQ/PV).
Develop, write, and review various validation deliverables, i.e., CSV‑E, Engineering Studies, etc.
Partner with cross‑functional partners to ensure sound validation strategy and smooth transitions to production go‑live.
Ensure adequate documentation within the Quality System.
Responsible for equipment design, implementation, and validation.
Qualifications
Validation experience bringing in equipment.
3+ years of validation experience.
Medical Device or regulated industry experience.
IQ/OQ/PQ qualification knowledge.
Plus
Preferably J&J before.
CMM validation.
Seniority level Mid‑Senior level
Employment type Contract
Job function Technology, Information and Media
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Base pay range $35.00/hr - $45.00/hr
Responsibilities
Develop, write, review, maintain, and revise manufacturing documentation, i.e., Process Work Instructions, Manufacturing Specifications, Inspection Procedures to support product Manufacturing.
Support development and execution of manufacturing equipment qualifications (URS/FAT/SAT/IQ).
Support development and execution of process validations (OQ/PQ/PV).
Develop, write, and review various validation deliverables, i.e., CSV‑E, Engineering Studies, etc.
Partner with cross‑functional partners to ensure sound validation strategy and smooth transitions to production go‑live.
Ensure adequate documentation within the Quality System.
Responsible for equipment design, implementation, and validation.
Qualifications
Validation experience bringing in equipment.
3+ years of validation experience.
Medical Device or regulated industry experience.
IQ/OQ/PQ qualification knowledge.
Plus
Preferably J&J before.
CMM validation.
Seniority level Mid‑Senior level
Employment type Contract
Job function Technology, Information and Media
#J-18808-Ljbffr