What are the responsibilities and job description for the Validation Engineer position at Joulé?
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 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 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. #M3
