Senior Manager, Commissioning and Qualification Engineer

Company: Bristol Myers Squibb
Location: Phoenix
Posted on: January 25, 2023

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. -In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

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

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

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

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Bristol Myers Squibb, Phoenix , Senior Manager, Commissioning and Qualification Engineer, Engineering , Phoenix, Arizona