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Associate Director - Engineering Compliance and C&Q

Bristol-Myers Squibb Company

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Phoenix, AZ
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Job Description

As posted by the hiring company

Job Overview:

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 Associate Director of Engineering Compliance and Commissioning and Qualification will lead and manage an experienced team of colleagues and contractors focused on Implementing Commissioning and Qualification (C&Q) supporting capital projects, as well as all aspects of Engineering operation compliance.

Major Responsibility

  • As part of the Engineering Operation Group, you will be responsible for driving the overarching Engineering Compliance program, including commissioning and qualification of new facilities, engineering change management based on Good Engineering Practice (GEP) and managing compliance in engineering organization.

Key Responsibilities

  • Lead a team of colleagues and contractors to achieve C&Q objectives aligned with capital project milestones and site goals.
  • Develop scope of work document (SOW) and bidding process to contract C&Q resources considering project planning, resource loading and project deliverables to support the site capital plan implementation.
  • Manage C&Q budget and ensure schedule adherence of the activities are aligned with Capital project schedule and site needs
  • Set Directions for Commissioning and Qualifications strategy for the site together with site stakeholders.
  • Lead the C&Q activities for the state of art Biologic Expansion through project life cycle (>$300MM) at Phoenix site according to Bristol Myers Squibb standards.
  • Oversee the Commissioning and Qualification program at the Phoenix site, ensuring adherence to Bristol Myers Squibb standards and regulatory requirements during project life cycle, working collaboratively with Manufacturing, Technical Services and Quality. The team 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
  • Responsible to act as a C&Q subject matter expert (SME), serving as the primary point of contact to present C&Q philosophies and strategies to Health Authority inspectors and auditors.
  • Support the inspection readiness program and the site compliance efforts by timely managing Engineering deviations, investigations, change controls and corrective actions plans, as well as the Engineering Change Management process based on the GEP
  • Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
  • Manage and develop staff, establish a staffing plan that includes adequate competent resourcing, hiring of key technical individuals as needed, and development and succession planning.

Qualifications & Experience

  • Engineering Bachelor’s degree; Mechanical, Chemical or Electrical Engineering or equivalent.
  • Minimum of 7 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.
  • Five years of previous successful people leadership experience.
  • Proficient in the C&Q process based on ISPE Baseline Guide (Volume 5 second edition) and ASTM E2500.
  • Demonstrated experience in implementing and leading C&Q activities in large capital projects
  • Experience supporting site audits from the regulatory agencies such as FDA, EMA, etc.
  • Demonstrated business and financial acumen with understanding of Capital and Operating budgets.
  • Experience Team-building and mentoring others.

VETERAN

#LI-Onsite

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.

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