Job Title: Senior Manufacturing Systems Engineer / Validation Engineer
Location: New Hampshire
Duration: 6+ Month Contract
Job Summary
We are seeking a Senior Manufacturing Systems Engineer / Validation Engineer with strong experience in medical device validation. The ideal candidate will lead validation activities for manufacturing processes, equipment, and analytical methods in a regulated environment.
Key Responsibilities
- Execute process and equipment validation (IQ/OQ/PQ)
- Develop and implement test method validation (TMV) strategies
- Support computerized system validation (CSV) for GxP systems
- Perform statistical analysis including MSA and capability studies
- Ensure traceability between risk controls, process parameters, and validation criteria
- Author and review validation protocols, reports, and documentation
- Collaborate with cross-functional teams (Manufacturing, Quality, R&D)
- Ensure compliance with regulatory and quality standards
Required Qualifications
- 10+ years of experience in medical device validation
- Strong hands-on experience with IQ/OQ/PQ, TMV, and CSV
- Knowledge of validation lifecycle and risk management practices
- Experience in regulated manufacturing environments
- Strong documentation and problem-solving skills
Preferred Qualifications
- Familiarity with ISO 13485, ISO 14971, and FDA regulations
- Experience supporting manufacturing systems and processes
Apply / Refer:
Abhi
Jr IT Recruiter | S4 Analytics
Phone: +1 (469)429-8068
Email: Abhi@s4analytix.com
