Head of Maintenance - Biologics

• Location:
  
  Framingham, MA

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

• Maintenance Execution: Lead preventive, corrective, condition-based maintenance, calibration, and periodic qualification. Maintain schedule compliance, backlog control, resource alignment, and timely risk escalation.
• Safety and Compliance: Ensure maintenance activities comply with HSE, cGMP, data-integrity, permit, LOTO, energy-isolation, contractor-safety, and documentation requirements. Support deviations, CAPAs, audits, and regulatory inspections.
• Reliability and Operational Support: Improve asset reliability and lifecycle performance through failure analysis, equipment criticality, condition monitoring, root cause analysis, and bad-actor elimination. Minimize maintenance‑related APU manufacturing downtime.
• Work and Contractor Management: Own maintenance workflows from work intake through closure. Manage contractors and vendors for safety, technical capability, quality, delivery, performance, and cost.
• Financial and People Leadership: Manage staffing, employee development, budgets, forecasts, service contracts, overtime, materials, and cost improvements without compromising safety, compliance, or reliability.
• Projects and Shutdowns: Provide maintainability requirements for projects, commissioning, qualification, turnover, and equipment changes. Lead maintenance support for shutdowns, outages, start-ups, emergencies, and return-to-service.

• Maintenance staffing, organization design, work allocation, and performance management within approved budgets.
• Maintenance work-management processes and priorities.
• Contractor and vendor selection within delegated authority.

• Timely completion of maintenance, calibration, and qualification activities.
• Maintenance HSE controls and regulatory compliance.
• Equipment reliability and maintenance-related APU downtime.
• Maintenance budget, contractor performance, and project maintainability.
• Inspection readiness and effective risk escalation.

• Production schedules, shutdowns, and equipment‑access constraints.
• Deviations, CAPAs, audit findings, and regulatory commitments.
• Capital projects, equipment changes, and obsolescence risks.
• Budget constraints, critical‑spare shortages, significant failures, and safety events.

Operations;
Quality, Validation and Metrology; HSE;
Engineering, Projects and Automation;
Procurement and Finance; and the Head of Site Engineering & Maintenance.

• Bachelor’s degree in engineering, maintenance management, life sciences, or a related field
• 7+ years of relevant experience, including 3+ years leading technical teams in regulated manufacturing.
• Demonstrated experience in maintenance execution, reliability, calibration, contractor management, budgeting, and shutdown support.
• Working knowledge of cGMP, data integrity, deviations, CAPAs, CMMS/EAM, safe-work permits, and LOTO.
• Strong communication, decision-making, and cross‑functional leadership skills.

• Biopharmaceutical or…