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Manager, Computer System Validation Cell Therapy, Bristol-Myers Squibb Company, Summit, NJ. Develop, review, and approve protocols and associated reports while adhering to a change management process by drawing on experience with, MS Windows client and server technologies, standard networking principles and technologies, current good practices (cGXP) requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry, International Society for Pharmaceutical Engineering (ISPE) guidance, 21 CFR Part 11 compliance, identifying and documenting user and functional requirements, and executing equipment qualification documents. Support the execution of equipment qualifications and validation protocols; support calibration, equipment qualification and validation activities; configure and document the configuration of computerized systems; develop validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls; provide direct oversight of CSV personnel providing hands-on leadership; support the continuous improvement of the Commissioning, Qualification and Validation (CQV) program; support laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area; own all lifecycle deliverables in the qualification of equipment and full CSV for single and multi-user computerized systems; review, prioritize, and respond to customer equipment qualification and support requests; provide technical support and guidance on calibration and equipment qualification issues, investigations, deviations and CAPA actions.

40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. $166,000/yr - $203,030/yr.

MINIMUM REQUIREMENTS:

Bachelor’s degree or foreign equivalent degree in Engineering, or a related field, and five (5) years of post-baccalaureate, progressive experience.

Must have experience with/in:

• MS Windows client and server technologies;
• Standard networking principles and technologies;
• Current good practices (cGXP) requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry;
• International Society for Pharmaceutical Engineering (ISPE) guidance;
• 21 CFR Part 11 compliance;
• Identifying and documenting user and functional requirements; and
• Executing equipment qualification documents.

The required skills do not need to be maintained over the full term of required experience.

May work remotely five (5) days every two (2) weeks within normal commuting distance of Summit, NJ.

The starting compensation for this job is a range from $166,000/yr - $203,030/yr, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance pr