What are the responsibilities and job description for the Process Validation Engineer position at Intellectt Inc?
Hi All,
One of my clients is looking Role : Process Validation Engineer , if you’re interested or your skills matches, please share with me your updated resume to sohail@intellectt.com
Job Title : Process Validation Engineer
Location : North Haven, Connecticut
Industry : Medical Device
Job Description :
We are seeking a Process Validation Engineer to support manufacturing process improvements, validations, and compliance activities within a regulated medical device environment. The ideal candidate will have hands-on experience in IQ / OQ / PQ validation protocols , process optimization , and regulatory compliance (FDA, ISO 13485, GMP) .
Key Responsibilities :
- Develop and execute process validation protocols (IQ, OQ, PQ) for new and existing manufacturing processes.
- Perform statistical data analysis to ensure process capability, stability, and reliability.
- Collaborate with cross-functional teams (Manufacturing, Quality, R&D) to ensure validation activities align with regulatory and business requirements.
- Conduct gap analysis and ensure compliance with FDA, ISO 13485, and GMP regulations.
- Support root cause analysis (RCA), CAPA investigations , and continuous process improvements.
- Author and review technical documents, including validation protocols, test method validations (TMV), SOPs, work instructions, and reports .
- Ensure compliance with industry risk management practices (pFMEA, dFMEA, risk assessments) .
- Assist in developing and optimizing cleanroom processes, sterilization validation, and material qualification .
- Provide technical support for new product introductions (NPI) and manufacturing transfers .
Required Qualifications :
