Senior Manager, Commissioning and Qualification Engineer

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us

Position Summary

The Commissioning and Qualification Engineer will work as an individual contributor or supervising contractors to perform Commissioning and Qualification (C&Q) activities.

Major Responsibility

As part of the Engineering Compliance and C&Q team, you will be responsible for executing commissioning and qualification activities supporting Capital Project implementation at Phoenix Site, AZ.

Key Responsibilities

• Ensure schedule adherence of C&Q activities aligned with Capital project schedule and site needs.
• Execute Commissioning and Qualification activities, ensuring adherence to Bristol Myers Squibb standards and regulatory requirements during project life cycle, working collaboratively with Manufacturing, Technical Services, Quality and Engineering functions. You will be responsible for:
  • Generate User Requirement Specifications (URS), Functional Requirement Specification (FRS) for critical Process Equipment and Utilities Systems.
  • Project Commissioning and Qualification Plan (PCQP) and perform System and Component Impact Assessments.
  • Support and document FATs and SATs
  • Prepare C&Q protocols and execute C&Q activities (IOQ)
  • Support M&ST in PQs and Ongoing requalification activities based on validation master plan
• Develop statement of work document (SOW) and support the bidding process to contract C&Q resources as needed, considering project planning, resource loading and project deliverables to support the site capital plan implementation.
• Oversee contractors to achieve C&Q objectives aligned with capital project milestones and site goals.

Qualifications & Experience

• Engineering Bachelor’s degree; Mechanical, Chemical or Electrical Engineering or equivalent.
• Minimum of 8 years of experience in a cGMP pharmaceutical, or other life sciences facility.
• Experience in Sterile Filling technology and GMP utilities such as HVAC, WFI, Clean Steam, Clean compressed air, Nitrogen, etc.
• Proficient in the C&Q process based on ISPE Baseline Guide (Volume 5 second edition) and ASTM E2500.
• Demonstrated experience in implementing C&Q activities in capital projects
• Experience supporting site audits from the regulatory agencies such as FDA, EMA, etc.

#LI-Onsite

VETERAN

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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