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

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.