Senior Manager Utilities Engineering

About the role

Be part of Amgen’s newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleXBatch facility will feature best-in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and will integrate sustainability innovations to reduce carbon and waste as part of Amgen’s plan to be a carbon-neutral company by 2027.

Responsibilities

• Site design, construction, start-up, and operational readiness:
  • Build a team of Utilities Engineers and serve as the main point of contact for the Utilities Engineering function.
  • Support the start-up of all site utility systems and transfer of ownership to the F&E utilities team.
  • Develop and implement long-term strategy for technical support of installed systems and equipment, including system setups for CMMS, etc.
  • Support the development and implementation of goals, objectives, and associated budgets for all utility engineering services, including mechanical and HVAC systems.
  • Ensure utility engineering programs are aligned with cGMP and safety requirements, local/global regulations, and Amgen Maintenance Excellence standards.
  • Ensure procedures are in place for cGMP and daily activities are followed by area personnel and contractors.
  • Ensure safety of all personnel during plant construction, start-up operations, and maintenance activities across multiple shifts, providing 24/7 plant and utility coverage.
• Site Operations:
  • Lead the Amgen NC F&E Utility Engineering staff supporting continuous clean and plant utility operations, including electrical and HVAC systems.
  • Accountable for system ownership for building and process utility systems and for supplier management, including:
    • GMP utilities such as Plant Utilities, Purified Water (PW), Water for Injection (WFI), Clean Steam, Clean Compressed Air, and Process Gases.
    • Non-GMP utilities such as waste management, electrical systems, boiler room operations, chilled water systems, plant steam, industrial gases, HVAC systems, and compressed air systems.
  • Manage system ownership by providing adequate resources and technical expertise, maintenance procedures, system validation support, performance monitoring, training materials, and ensuring operating procedures are followed.
  • Develop and support equipment maintenance programs, ensure availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order.
  • Ensure site readiness and compliance for internal audits, external agency audits, and partner visits.
  • Lead and support continuous improvement initiatives including improvements to safety, reliability, efficiency, and sustainability.
  • Maintain and improve utility system capability and reliability in partnership with engineering leadership and technical staff.
  • Collaborate effectively with key customers and support groups (e.g., Manufacturing, Quality, Environmental Health & Safety, and Engineering).
  • Have oversight and lead execution of complex utilities-related initiatives and projects; provide expertise and resources for capital project execution.
  • Establish clear expectations and priorities for staff; encourage a culture of continuous improvement, partnership, and knowledge sharing.
  • Provide development opportunities, feedback, and actively listen to staff.
  • Maintain and develop key performance indicators of maintenance performance; supervise, assess, and develop staff; ensure targets and milestones are completed on time and on budget.
  • Participate in the budgeting process for Utilities, including forecasting costs, managing expenditures, and ensuring efficient allocation of resources.

Up to 10% domestic/international travel may be required.

Requirements

• Education and Experience:
  • Doctorate degree and 2 years of engineering experience
  • OR Masters degree and 6 years of engineering experience
  • OR Bachelors degree and 8 years of engineering experience
  • OR Associates degree and 10 years of engineering experience
  • OR High school diploma / GED and 12 years of engineering experience
• And 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.

Qualifications

• Preferred:
  • 6+ years of experience in Utility Engineering within the biotechnology and/or pharmaceutical or other regulatory environments.
  • 3+ years of experience ensuring compliance in a highly regulated environment.
  • Demonstrated interpersonal and facilitation skills and ability to work in a collaborative, team-based environment.
  • Ability to lead multiple tasks and effectively set priorities.
  • Direct knowledge of GMP utilities such as Purified Water (PW), Water for Injection (WFI), Clean Steam, Clean Compressed Air, and Process Gases, as well as non-GMP utilities including waste management, electrical systems, boiler room operations, chilled water systems, plant steam, industrial gases, HVAC systems, and compressed air systems.
  • Strong knowledge of Computerized Maintenance Management Systems.
  • Demonstrated skill in analyzing and improving facilities-related quality systems.
  • Ability and willingness to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
  • Strong leadership, technical writing, and communication/presentation skills.
  • Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• A discretionary annual bonus program (or sales-based incentive plan for field sales representatives).
• Stock-based long-term incentives.
• Award-winning time-off plans and bi-annual company-wide shutdowns.
• Flexible work models, including remote work arrangements where possible.