Senior Manager, Commissioning and Qualification Engineer
Company: Bristol Myers Squibb
Posted on: January 25, 2023
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.
The Commissioning and Qualification Engineer will work as an
individual contributor or supervising contractors to perform
Commissioning and Qualification (C&Q) activities.
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
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
Experience supporting site audits from the regulatory agencies such
as FDA, EMA, etc.
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 email@example.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
Any data processed in connection with role applications will be
treated in accordance with applicable data privacy policies and
Keywords: Bristol Myers Squibb, Phoenix , Senior Manager, Commissioning and Qualification Engineer, Engineering , Phoenix, Arizona
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