Senior Manager Instrumentation and Maintenance

About the role

Join Amgen’s newest and most advanced drug substance manufacturing plant. The Amgen FleX batch facility combines the latest in single-use technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The facility will feature best-in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and integrate sustainability innovations to reduce carbon and waste, aligning with Amgen’s plan to be a carbon-neutral company by 2027.

The Senior Manager Instrumentation and Maintenance will join the Facilities & Engineering (F&E) group, reporting to the F&E Director. In this role, you will oversee the Maintenance and Instrumentation team, providing technical and administrative leadership to a large, diverse group of craft-oriented personnel, including maintenance and instrumentation technicians. You will support 24/7 operations and ensure the reliability and compliance of plant systems.

Responsibilities

• Build and lead a team of Maintenance and Instrumentation professionals, serving as the main point of contact for the Maintenance function.
• Develop and implement a long-term strategy for technical support of ongoing operations and maintenance of installed systems and equipment, including CMMS setups.
• Support the development and implementation of goals, objectives, and budgets for all maintenance services, including site maintenance and calibration programs.
• Ensure Preventive Maintenance and Calibration programs align with cGMP, safety requirements, local/global regulations, and Amgen Maintenance Excellence standards.
• Ensure procedures are in place for cGMP compliance and that daily activities are followed by area personnel and contractors.
• Ensure the safety of all personnel during plant construction, start-up operations, and maintenance activities across multiple shifts, providing 24/7 plant and utility coverage.
• Lead a team of Maintenance and Instrumentation professionals, serving as the main point of contact for the function.
• Manage maintenance-related system ownership by providing adequate resources, technical expertise, maintenance procedures, system validation support, performance monitoring, training materials, and ensuring adherence to operating procedures.
• Execute the maintenance and calibration program to support 24/7 reliability of plant operations.
• Ensure site readiness and compliance for internal audits, external agency audits, and partner visits.
• Lead and support continuous improvement initiatives, including safety, reliability, efficiency, and sustainability enhancements.
• Maintain and improve plant capability and equipment 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).
• Oversee and lead the execution of complex facilities/maintenance-related initiatives and projects, providing expertise and resources for capital project execution.
• Establish clear expectations and priorities for staff, fostering a culture of continuous improvement, partnership, and knowledge sharing.
• Provide development opportunities, feedback, and actively listen to staff.
• Maintain and develop key performance indicators for maintenance performance, supervising, assessing, and developing staff to ensure targets and milestones are completed on time and on budget.
• Participate in the budgeting process for Maintenance, including forecasting costs, managing expenditures, and ensuring efficient resource allocation.
• Up to 10% domestic/international travel.

Requirements

We seek an automation professional who enjoys challenges and is motivated to serve patients. The ideal candidate meets the following qualifications:

• Basic Qualifications:
  • High school diploma/GED and 12 years of engineering experience, or
  • Associate’s degree and 10 years of engineering experience, or
  • Bachelor’s degree and 8 years of engineering experience, or
  • Master’s degree and 6 years of engineering experience, or
  • Doctorate degree and 2 years of engineering experience.

  In addition to meeting at least one of the above requirements, you must have a minimum of 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Managerial experience may run concurrently with the required technical experience.

• Preferred Qualifications:
  • 6+ years of experience in engineering or maintenance within biotechnology, pharmaceutical, or other regulatory environments, or military experience.
  • 3+ years of experience ensuring compliance in a highly regulated environment.
  • Demonstrated interpersonal and facilitation skills, with the ability to work in a collaborative, team-based environment.
  • Ability to lead multiple tasks and effectively set priorities.
  • Strong knowledge of maintenance management and Computerized Maintenance Management Systems (CMMS).
  • Demonstrated skill in analyzing and improving facilities-related quality systems.
  • Ability and willingness to mentor and develop engineering staff, embracing a team-based culture that relies on collaboration for effective decision-making.
  • Strong leadership, technical writing, and communication/presentation skills.
  • Work schedule flexibility to support 24/7 operations, including occasional after-hours engineering coverage.

Benefits

Amgen supports your professional and personal growth with a competitive benefits package and a collaborative culture. In addition to the base salary, Amgen offers comprehensive Total Rewards Plans aligned with local industry standards.