Head of Maintenance - Biologics

Sanofi•Framingham, MA

5d•Onsite

About The Position

The Head of Maintenance leads maintenance operations for biologics manufacturing in Framingham, Massachusetts. The role oversees preventive, corrective, and condition-based maintenance, calibration, and periodic qualification, while ensuring schedule compliance, backlog control, adequate resources, and timely escalation of risk. The position is accountable for safe, compliant maintenance work and equipment reliability in a regulated manufacturing environment. It manages maintenance workflows and external contractors and vendors, along with staffing, employee development, budgets, forecasts, service contracts, overtime, materials, and cost improvements. The role also supports projects and equipment changes, commissioning and qualification, shutdowns, outages, start-ups, emergencies, and return-to-service. The Head of Maintenance works across Operations; Quality, Validation and Metrology; HSE; Engineering, Projects and Automation; Procurement and Finance; and the Head of Site Engineering & Maintenance. The position is responsible for inspection readiness, regulatory compliance, maintenance-related manufacturing downtime, contractor performance, and project maintainability.

Requirements

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.

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, backlog control, resource alignment, and timely risk escalation.
Ensure maintenance work complies 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 without compromising safety, compliance, or 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.
Make decisions on maintenance staffing, organization design, work allocation, performance management within approved budgets, maintenance work-management processes and priorities, and contractor and vendor selection within delegated authority.
Ensure timely completion of maintenance, calibration, and qualification activities; maintenance HSE controls and regulatory compliance; equipment reliability; budget and contractor performance; project maintainability; inspection readiness; and effective risk escalation.
Coordinate with Operations; Quality, Validation and Metrology; HSE; Engineering, Projects and Automation; Procurement and Finance; and the Head of Site Engineering & Maintenance.