What are the responsibilities and job description for the Validation Engineer position at System One?
Job Title: Validation Engineer
Location: Piscataway, NJ
Hours / Schedule: Monday - Friday, 8am - 5pm, some flex as needed, may require overnight/weekend work
Type: Contract - Hire
Responsibilities
- Develop qualification protocols and policies for equipment, utilities, and instruments
- Perform risk assessments, including FMEA, and ensure compliance with FDA/EU regulations
- Author summary reports and develop remediation plans for validation failures
- Conduct GAP analysis and provide recommendations for existing qualifications
- Lead protocol execution and support validation projects across functional areas
- BS or MS in a related Engineering field
- Minimum 4 years of industry experience in commissioning, validation and qualification in the life sciences / biotechnology industry
- Experience developing validation protocols (IQ/OQ/PQ) and qualification plans
- Strong knowledge of 21 CFR Part 210/211, ICH Q7, and FDA / EU compliance
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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