Manager, Principal Compliance Engineer

Role: Principal Compliance Engineer, ECQ at Bristol Myers Squibb, overseeing equipment validation and compliance for the Summit, NJ facility. Responsibilities include performing gap analyses, leading equipment reviews, and ensuring adherence to cGMP, GXP, and regulatory standards (FDA, EMA, USP, EP, JP). The role involves managing a team responsible for periodic reviews, supporting regulatory audits, and leading compliance projects to maintain validated states of equipment and policies. Core duties also encompass revising departmental procedures, participating in historical performance reviews, and ensuring documentation aligns with current regulations. Qualifications: BS in Engineering or Science, minimum 5 years’ experience in FDA-regulated industries, with expertise in pharmaceutical manufacturing, laboratory systems, and equipment. Advanced knowledge of cGMP, GxP, 21 CFR part 11, and validation requirements is required. Preferred skills include strong communication, organization, and proficiency in Microsoft Office and database systems. The environment is primarily office-based, with laboratory or GMP area entry requiring appropriate PPE. Physical demands include occasional lifting up to 25 lbs. The position is onsite in Summit, NJ. Compensation ranges from $106,630 to $129,214, with comprehensive benefits, including wellbeing support, retirement plans, and flexible time off.