Senior Manager Instrumentation and Maintenance

Role Summary

Senior Manager, Instrumentation and Maintenance leads the Maintenance and Instrumentation team within Facilities & Engineering, providing technical and administrative leadership to a diverse group of craft professionals and technicians. This role supports 24/7 operations and oversees site design, construction, start-up, and operational readiness, and develops long-term technical strategy for ongoing maintenance of installed systems and equipment, including CMMS integration. The position emphasizes safety, regulatory compliance, and continuous improvement in a highly regulated manufacturing environment.

Responsibilities

• Build and lead a team of Maintenance and Instrumentation professionals and serve as the main point of contact for the Maintenance function.
• Develop and implement long term strategy for technical support for ongoing operations and maintenance of installed systems and equipment including system setups for CMMS, etc.
• Support the development and implementation of goals and objectives and associated budgets for all maintenance services including but not limited to site maintenance and calibration programs.
• Ensure Preventive Maintenance and Calibration programs are aligned with cGMP and safety requirements, local/global regulations, and Amgen Maintenance excellence standards.
• Ensure that 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.
• Manage maintenance related system ownership by providing adequate resources and technical talent and expertise, maintenance procedures, providing adequate system validation support, monitoring performance data, providing adequate training materials, and ensuring operating procedures are followed.
• Responsible for execution of maintenance and calibration program to support 24/7 reliability of plant operations.
• Ensures 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 plant capability and equipment reliability in partnership with engineering leadership and technical staff.
• Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Environmental Health & Safety, and Engineering).
• Have oversight and lead execution of complex facilities/maintenance related initiatives and projects. Provide expertise and resources for capital project execution.
• Establish clear expectations and priorities to 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, develop staff and ensure that all 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 allocation of resources.

Qualifications

• Required: 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.
• Required: In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.
• Preferred: 6+ years’ experience in engineering or maintenance within the biotechnology and/or pharmaceutical or other regulatory environments, or Military experience
• Preferred: 3+ years’ experience of ensuring compliance in a highly regulated environment
• Preferred: Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment
• Preferred: Ability to lead multiple tasks and effectively set priorities
• Preferred: Strong knowledge of maintenance management and Computerized Maintenance Management Systems
• Preferred: Demonstrated skill in analyzing and improving facilities related quality systems
• Preferred: Ability and willingness to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
• Preferred: Strong leadership, technical writing, and communication/presentation skills.
• Preferred: Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.

Additional Requirements

• Up to 10% domestic/international travel