Senior Manager, Maintenance – GMP Peptide Facility

Senior Manager, Maintenance

This role reports to the Site Lead. The Senior Manager, Maintenance leads the maintenance and reliability function for a GMP peptide manufacturing facility, providing high-level support to the Site Operations and Engineering organization through predictive and preventive maintenance programs for all production, utility, and facility equipment. This position analyzes, troubleshoots, and communicates maintenance problems and concerns in the following areas: electrical, mechanical, plumbing, compressed air and process gases, HVAC, and clean utilities, as they relate to equipment and controlled environments in the facility.

The Senior Manager works with general supervision and will interact with the Site Lead regularly to receive guidance and feedback. Many non-routine activities will require the Site Lead's advance approval.

• Lead a group of maintenance technicians, supervisors, and managers across a multi-shift, multi-discipline operation.

• Own the predictive and preventive maintenance program for all GMP equipment, including peptide synthesizers, preparative HPLC and purification systems, lyophilizers, filtration and TFF skids, reactors, isolators and hoods, autoclaves, and associated controls.

• Maintain and reliably operate facility and clean utilities, including HVAC and cleanroom environmental systems, purified water/WFI, clean steam, compressed air, nitrogen and other process gases, and chilled and hot water systems.

• Document maintenance, technical, and other data on predictive/preventive maintenance charts, as required.

• Diagnose and repair equipment and systems throughout the facility, including electrical, mechanical, plumbing, compressed air, PLC/controls, and HVAC repairs.

• Identify facility and equipment issues and develop an ongoing strategy to chart trends and take remedial action using a predictive maintenance approach.

• Communicate to management all issues that could result in safety risks, product quality impact, or loss to Hims or its associates.

• Work as directed in all areas of the facility to maintain safety and health standards.

• Perform and oversee calibration and testing procedures on equipment to ensure accurate operation and compliance with quality standards.

• Conduct regular checks and measurements to verify equipment performance, including temperature, pressure, speed, and other relevant parameters.

• Maintain calibration records and documentation in compliance with cGMP and other regulatory requirements.

• Ensure that all equipment meets regulatory and quality standards and take corrective actions to address any non-compliance issues.

• Collaborate with Quality Assurance, Validation, and Regulatory Affairs to implement and maintain proper documentation, including equipment logs, maintenance records, change controls, deviations/CAPAs, and qualification and validation reports.

• Support equipment and facility qualification (IQ/OQ/PQ), commissioning, and requalification activities, and maintain the validated state of equipment through the change control process.

• Respond promptly to equipment breakdowns, emergencies, and production interruptions to minimize downtime.

• Work closely with production personnel to coordinate repairs and planned maintenance and minimize disruptions to the manufacturing schedule.

• Develop and manage the maintenance budget, spare parts strategy, and external contractor and vendor relationships.

• Identify opportunities for process optimization, efficiency improvements, and cost savings related to equipment maintenance and operation.

• Participate in cross-functional teams to implement improvement projects and contribute to a continuous improvement culture within the organization.

• Stay updated with industry trends, technological advancements, and best practices related to pharmaceutical and peptide manufacturing equipment maintenance.

• Make sure all assets, parts, and work orders are updated and tracked in CMMS for all facility equipment.

• Bachelor's degree in Engineering, Maintenance, or a related technical field; equivalent technical training/certification may be considered.

• 5+ years of maintenance or engineering experience in pharmaceutical manufacturing or another highly regulated environment.

• 10+ years of people leadership experience, including leading hourly and salaried technical teams.

• Strong working knowledge of cGMP requirements and maintaining equipment in a GMP environment.

• Hands-on expertise troubleshooting and maintaining advanced mechanical, electrical, and…