QA Engineering Manager, Equipment & Facilities

Biopharma Careers; Summit West (CA); On-site; USD 100,000 - 121,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

Financial Well-being

Job summary

Bristol Myers Squibb is seeking a Manager, QA Engineering to oversee equipment, lab methods, utilities and facilities validation and technology transfer in a fast-paced manufacturing setting.

Qualified candidates have a Bachelor of Science and at least five years in pharmaceutical quality or related roles, with experience in IQ/OQ/PQ, UAT and GMP document reviews. Strong leadership and Ms Office proficiency are essential.

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 Maximo and quality systems software (BMSDocs, Infinity/Valgenesis).
• Must be able to recognize and group technical/scientific attributes and drive science-based decisions across job function.

Responsibilities

• Support QA Engineering activities for equipment/utility/facility qualification.
• Review GMP documents and procedures for accuracy and compliance.
• Ensure calibration, maintenance programs, and validation plans are appropriate.
• Lead investigations and CAPA with thorough root-cause analysis and corrective actions.
• Coach/Develop direct reports when in a people-manager role.

Skills

GMP knowledge

Quality systems

Risk management

URS design

IQ/OQ/PQ protocols

UAT testing

Maximo

BMSDocs

Valgenesis

Infinity

Leadership

Documentation review

Education

Bachelor of Science

Tools

Maximo

BMSDocs

Infinity/Valgenesis

Job description

Bristol Myers Squibb is seeking a Manager, QA Engineering to oversee equipment, lab methods, utilities and facilities validation and technology transfer in a fast-paced manufacturing setting.

Qualified candidates have a Bachelor of Science and at least five years in pharmaceutical quality or related roles, with experience in IQ/OQ/PQ, UAT and GMP document reviews. Strong leadership and Ms Office proficiency are essential.