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Senior Manager, CTO Plant Engineering: Lead Manufacturing Operations

2 months ago

Summit, New Jersey, United States Bristol-Myers Squibb Full time
About the Role

Bristol-Myers Squibb is seeking a highly skilled Senior Manager, CTO Plant Engineering to lead the efficient and reliable operation of manufacturing facilities and utilities across all Summit West Cell Therapy Operations.

Key Responsibilities
  • Provide engineering support for mechanical, electrical, and plumbing (MEP) manufacturing-related utility systems, ensuring compliance with GMPs, industry best practices, and BMS directives.
  • Coordinate projects and maintenance activities with operations to minimize disruptions to controlled environments (DCE) for controlled and uncontrolled outages.
  • Manage maintenance technicians and outside service providers, performing routine and corrective work orders related to HEPA filter certifications, air balancing, and filter integrity testing.
  • Act as lead project manager on smaller capital/expenditure projects, identifying user requirements and engaging with A/E firms and construction management firms for execution.
  • Coordinate all field work to ensure proper safety procedures are in place, including PreTask Plans (PTP), Job Hazard Analysis (JHA), Process Analysis (PHA), and Pre-Startup Safety Reviews (PSSRs).
  • Work with operations and quality organizations to procure benchtop capital equipment and assess available space and utilities required in the field.
  • Engage with facilities, maintenance, ECQ, global engineering, and external resources to engineer solutions.
  • Act as engineering lead to continuously assess adherence with BMS and regulatory standards against guidance documents, identifying and communicating gaps and working with the engineering team to remediate as needed.
  • Review, redline, approve, and update engineering drawings and other technical documentation to ensure it remains current.
  • Initiate facility and engineering-related change controls as required to obtain quality endorsement of proposed changes.
  • Partner with facility and reliability engineers to investigate adverse trends and execute CAPAs as required.
  • Collaborate with other functions, such as manufacturing operations, quality assurance, facilities, ECQ, and EHS, for an inclusive approach in determining successful outcomes.
Qualifications and Experience
  • Bachelor's degree in mechanical engineering, chemical engineering, or a related field.
  • Proven experience (10+ years) in a similar role within the pharmaceutical or related industry.
  • In-depth knowledge of pharmaceutical manufacturing processes, equipment, and systems, including HVAC, mechanical and electrical systems, cleanrooms, and process automation.
  • Strong understanding of regulatory requirements, such as GMP, GDP, and OSHA guidelines.
  • Previous experience in facility operations and maintenance, design, construction, and qualification.
  • Proficient in using computer-aided design (CAD) software and other engineering tools.
  • Excellent problem-solving and analytical skills with the ability to identify and resolve complex technical issues.
  • Effective communication and interpersonal skills to collaborate with cross-functional teams and external stakeholders.
  • Detail-oriented with a strong commitment to quality, safety, and compliance.
  • Ability to manage multiple projects simultaneously and prioritize tasks effectively.