Head of Maintenance - Biologics

Sanofi • Framingham, MA

4d • Onsite

About The Position

The Head of Maintenance leads maintenance execution and reliability for biologics manufacturing in Framingham, Massachusetts. The role oversees preventive, corrective, and condition-based maintenance, calibration, and periodic qualification while maintaining schedule compliance, controlling backlogs, aligning resources, and escalating risks in a timely manner.

The position ensures maintenance work complies with HSE, cGMP, data-integrity, permit, LOTO, energy-isolation, contractor-safety, and documentation requirements, and supports deviations, CAPAs, audits, and regulatory inspections. It improves asset reliability and lifecycle performance, minimizes maintenance-related APU manufacturing downtime, and manages work from intake through closure, including contractor and vendor performance.

The role has responsibility for staffing, employee development, budgets, forecasts, service contracts, overtime, materials, and cost improvements. It also provides maintainability input for projects, commissioning, qualification, turnover, and equipment changes, and leads maintenance support for shutdowns, outages, start-ups, emergencies, and return-to-service. Decision authority includes maintenance organization and staffing, work allocation and priorities, performance management within approved budgets, and contractor or vendor selection within delegated authority.

Requirements

• Bachelor’s degree in engineering, maintenance management, life sciences, or a related field.
• At least 7 years of relevant experience, including at least 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.

Nice To Haves

• Biopharmaceutical or pharmaceutical manufacturing experience, including single-use technologies.
• Knowledge of FMEA, root cause analysis, criticality assessment, condition monitoring, and lifecycle planning.
• Professional certification such as PE, CMRP, CRL, PMP, CEM, or Lean Six Sigma.

Responsibilities

• Lead preventive, corrective, and condition-based maintenance, calibration, and periodic qualification.
• Maintain schedule compliance, control maintenance backlogs, align resources, and escalate risks promptly.
• 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.
• 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.
• Own maintenance workflows from work intake through closure.
• Manage contractors and vendors for safety, technical capability, quality, delivery, performance, and cost.
• Manage staffing, employee development, budgets, forecasts, service contracts, overtime, materials, and cost improvements while maintaining safety, compliance, and reliability.
• Provide maintainability requirements for projects, commissioning, qualification, turnover, and equipment changes.
• Lead maintenance support for shutdowns, outages, start-ups, emergencies, and return-to-service.
• Manage maintenance staffing, organization design, work allocation, and performance within approved budgets.
• Set maintenance work-management processes and priorities; select contractors and vendors within delegated authority.
• Remain informed of production schedules, shutdowns, equipment-access constraints, deviations, CAPAs, audit findings, regulatory commitments, capital projects, equipment changes, obsolescence risks, budget constraints, critical-spare shortages, significant failures, and safety events.

Benefits

• Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Company employee benefit programs; details are available through the company benefits information.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior