Senior Manager, Maintenance – GMP Peptide Facility

Hims & Hers•Menlo Park, CA

13d•$155,000 - $175,000

About The Position

The Senior Manager, Maintenance leads the maintenance and reliability function for a GMP peptide manufacturing facility and supports Site Operations and Engineering through predictive and preventive maintenance programs for production, utility, and facility equipment. Reporting to the Site Lead, the role works with general supervision and regularly interacts with the Site Lead for guidance and feedback; many non-routine activities require the Site Lead’s advance approval. The position oversees maintenance teams across a multi-shift, multi-discipline operation and maintains GMP manufacturing equipment and facility systems, including clean utilities and controlled environments. It is responsible for equipment troubleshooting, calibration, documentation, qualification, reliability, and regulatory compliance, as well as responding to breakdowns and coordinating maintenance with production. The role also manages maintenance budgets, spare parts, vendors, and contractors, and drives operational improvements and cost savings.

Requirements

Bachelor’s degree in Engineering, Maintenance, or a related technical field; equivalent technical training or certification may be considered.
At least 5 years of maintenance or engineering experience in pharmaceutical manufacturing or another highly regulated environment.
At least 10 years of people leadership experience, including leading hourly and salaried technical teams.
Strong working knowledge of cGMP requirements and equipment maintenance in a GMP environment.
Hands-on expertise troubleshooting and maintaining advanced mechanical, electrical, and automated equipment, including PLC and CMMS systems.
Experience leading preventive and predictive maintenance programs, interpreting technical data, and driving equipment reliability and continuous-improvement initiatives.
Demonstrated ability to lead, develop, and assess technical talent; delegate complex work; and build effective shift and staffing structures.
Experience partnering across multiple facilities or teams to implement scalable maintenance systems and solve network-level operational challenges.
Strong written and verbal communication skills, including the ability to present recommendations to senior leaders.
Ability to meet the physical requirements of the role, including lifting up to 50 pounds, working at heights, climbing ladders and stairs, and operating safely in an industrial environment.
Availability to support urgent operational needs outside regular business hours.

Nice To Haves

Experience in pharmaceutical, API, peptide, or other GMP manufacturing environments.
Technical certification or formal training in electrical, mechanical, HVAC, plumbing, compressed air, or PLC systems.
Advanced degree or training in engineering, maintenance, Lean, Six Sigma, or a related discipline.
Spanish language skills.

Responsibilities

Lead maintenance technicians, supervisors, and managers across a multi-shift, multi-discipline operation.
Own predictive and preventive maintenance programs for 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 utility systems, 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 and preventive maintenance charts as required.
Diagnose and repair electrical, mechanical, plumbing, compressed air, PLC/controls, and HVAC equipment and systems throughout the facility.
Identify facility and equipment issues, chart trends, and develop strategies for remedial action using predictive maintenance.
Communicate issues that could result in safety risks, product quality impacts, or loss to Hims or its associates.
Work throughout the facility as directed to maintain safety and health standards.
Perform and oversee equipment calibration and testing to ensure accurate operation and compliance with quality standards.
Conduct regular checks and measurements to verify equipment performance, including temperature, pressure, and speed.
Maintain calibration records and documentation in compliance with cGMP and other regulatory requirements.
Ensure equipment meets regulatory and quality standards and take corrective action when requirements are not met.
Collaborate with Quality Assurance, Validation, and Regulatory Affairs on equipment logs, maintenance records, change controls, deviations/CAPAs, and qualification and validation reports.
Support equipment and facility qualification (IQ/OQ/PQ), commissioning, and requalification, and maintain validated equipment status through change control.
Respond promptly to equipment breakdowns, emergencies, and production interruptions to minimize downtime.
Coordinate repairs and planned maintenance with production personnel to minimize manufacturing schedule disruptions.
Develop and manage the maintenance budget, spare parts strategy, and external contractor and vendor relationships.
Identify process optimization, efficiency improvement, and cost-saving opportunities related to equipment maintenance and operation.
Participate in cross-functional improvement projects and contribute to a continuous improvement culture.
Stay current with industry trends, technological advancements, and best practices for pharmaceutical and peptide manufacturing equipment maintenance.
Ensure assets, parts, and work orders for facility equipment are updated and tracked in the CMMS.