Senior Manager, Maintenance & Calibration Operations

Responsibilities:
- Lead continuous improvement of GMP Maintenance and Calibration programs for California Facilities and Engineering.
- Serve as the Maintenance & Calibration representative on CAP/Opex projects across all phases of the project lifecycle.
- Manage maintenance and calibration planning and scheduling team to ensure timely and compliant execution of work.
- Manage QC Equipment Management team and associated calibration activities.
- Manage the MRO Parts group.
- Review and manage departmental budgets (forecasting, purchase orders, reconciliations, and cost allocation strategies).
- Ensure completion and documentation of quality investigations, deviations/CAPAs, and change controls related to maintenance and calibration.
- Establish, review, and manage service contracts in collaboration with Legal and Procurement.
- Ensure maintenance and calibration activities are executed in accordance with cGMP regulations, safety standards, and site quality systems.
- Serve as Facilities representative in regulatory audits where required.
- Participate in design and technical reviews from a maintenance, calibration, and lifecycle management perspective.
- Perform other duties as assigned in support of Facilities and Engineering objectives.

Required Skills/Qualifications:
- Demonstrated experience managing GMP maintenance and calibration programs in a regulated manufacturing environment.
- Strong knowledge of cGMP requirements, quality systems, and regulatory expectations.
- Experience supporting capital projects and interfacing with cross-functional engineering teams.
- Proven ability to manage budgets, service contracts, and vendor performance.
- Strong leadership, communication, and organizational skills.

Desired Skills:
- Experience managing maintenance and calibration teams in a pharmaceutical or biotech environment.
- Experience driving business process improvements in maintenance, calibration, or engineering functions.
- Experience in Regulatory Agency audits.

Education:
- Bachelor’s degree in Engineering, Science, or related technical discipline, or equivalent combination of education and experience.

Equipment/Tools:
- Standard office equipment and CMMS (computerized maintenance management systems) used to manage GMP maintenance and calibration activities.

Supervisory Responsibility:
- Direct oversight of Planning and Scheduling, MRO Parts, and QC Equipment teams.

Work Conditions:
- Standard business hours with flexibility to support off-hours maintenance or project activities as required.
- Onsite role supporting GMP facilities and operations.
- Limited travel as required to support projects, vendors, or site activities.