What are the responsibilities and job description for the Validation Engineer position at System One Holdings, LLC?
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
Requirements
Benefits
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.
