Senior Manager, Maintenance & Calibration

The Senior Manager, Maintenance & Calibration will lead the development, implementation, and execution of maintenance and calibration programs for the GMP manufacturing facility. This role is hands-on during facility startup, supporting commissioning and qualification (C&Q) activities, and will transition into building and leading a high-performing maintenance organization responsible for ongoing GMP compliance, asset reliability, and continuous improvement. This position will be based in Hayward, CA at our Huntwood Facility. **If any of the below describes you, we would love to meet you!** • Strong technical leader with the ability to operate at both strategic and hands-on levels • Experience supporting startup, commissioning, and GMP qualification activities • Proven ability to build maintenance programs from the ground up • Collaborative leader capable of integrating with Facilities, Manufacturing, QC, and Engineering teams • Continuous improvement mindset with focus on reliability, uptime, and compliance ### Key Responsibilities • Serve as a core team member supporting facility startup, commissioning, and operational readiness • Support development and execution of commissioning plans, qualification protocols and reports, turnover packages, and system walkdowns • Design, implement, and scale a GMP-compliant maintenance and calibration program • Establish and maintain a Computerized Maintenance Management System (CMMS) • Develop maintenance and calibration SOPs, job plans, intervals, and standard work instructions • Ensure maintenance and calibration requirements are embedded in system design and project turnover • Develop spare parts strategies, critical equipment lists, and asset hierarchies • Develop and execute preventive, predictive, and corrective maintenance programs to maximize reliability and uptime • Coordinate contractor and vendor activities for maintenance and calibration services • Recruit, train, and mentor maintenance staff while fostering a safety-first, GMP-compliant culture • Partner with cross-functional teams to support facility modifications and manufacturing operations ### Skills, Knowledge & Expertise • 10+ years of experience in maintenance, reliability, or facilities engineering in a GMP or regulated environment • Direct experience supporting facility startup, commissioning, and qualification • Strong knowledge of GMP / GDP requirements, equipment qualification (IQ/OQ/PQ) and CMMS systems and maintenance program development • Experience managing utilities and process equipment (e.g., HVAC, clean utilities, process skids) • Demonstrated ability to lead teams and cross-functional initiatives ### Job Benefits - Medical, Dental and Vision Insurance - Basic Life, AD&D, Short- and Long-Term Disability Insurance - 401k with Company Match up to 4% - Company Equity - Generous Paid Time Off including 18 Company Holidays (with a summer and winter shutdown), Vacation, and Wellness Time - Annual Lifestyle Account for reimbursement of fitness programs, equipment and more - Employee Stock Purchase Program (ESPP) - Flexible Spending Accounts (Commuter/Parking, Dependent Care & Healthcare) - Student Debt Program (Company Contribution to Loans) - Mental Health Wellness Program - Subsidized onsite lunch program - Onsite Gym Facilities - Paid Parental Leave And More!