QA Engineering Manager – Equipment & Facilities

Bristol-Myers Squibb; Summit, Northern (NJ, KY); Hybrid; USD 101,000 - 121,000; Full time

Benefits offered by this job

Health Coverage

401(k) Plan

Paid Time Off

Job summary

Bristol Myers Squibb is seeking a Manager, QA Engineering to provide quality oversight for Site Technology Transfer activities in a fast-paced manufacturing facility in Summit, NJ. The role covers equipment, utilities, and facility qualification, review of validation documents, and driving data integrity across QA processes.

The position may be individual contributor or people manager, with responsibilities to lead cross-functional teams and ensure compliance with global regulatory requirements.

Qualifications

• Must have GMP, Quality, and in-depth risk management knowledge.
• Experience in design of user requirement specifications, IQ/OQ/PQ protocols, user acceptance testing and other equipment/utility/facility qualification documentation.
• Must be fluent in standard Microsoft Office software; experience in CMMS and quality systems software.

Responsibilities

• Support activities for the QA Engineering group as assigned.
• Review and validate system GMP documents (operational and maintenance procedures).
• Ensure calibration/maintenance programs and qualification protocols are up to date.
• Assist with investigations and CAPA, root cause analysis, and corrective actions.
• Lead or coach a team of professionals and collaborate cross-functionally.

Skills

GMP knowledge

Quality risk management

Documentation review

Cross-functional collaboration

People management

Education

Bachelor of Science degree

Tools

Maximo

BMSDocs

Infinity/Valgenesis

Job description

Bristol Myers Squibb is seeking a Manager, QA Engineering to provide quality oversight for Site Technology Transfer activities in a fast-paced manufacturing facility in Summit, NJ. The role covers equipment, utilities, and facility qualification, review of validation documents, and driving data integrity across QA processes.

The position may be individual contributor or people manager, with responsibilities to lead cross-functional teams and ensure compliance with global regulatory requirements.