Head of Maintenance - Biologics
About The Position
The Head of Maintenance leads maintenance activities for biologics manufacturing in Framingham, Massachusetts. The role oversees preventive, corrective, and condition-based maintenance, calibration, and periodic qualification, ensuring schedule compliance, backlog control, resource alignment, and timely risk escalation. It is responsible for maintenance safety and compliance with HSE, cGMP, data-integrity, permit, LOTO, energy-isolation, contractor-safety, and documentation requirements, and supports deviations, CAPAs, audits, and regulatory inspections. The position improves equipment reliability and lifecycle performance through failure analysis, equipment criticality assessment, condition monitoring, root cause analysis, and bad-actor elimination, while minimizing maintenance-related APU manufacturing downtime. It owns maintenance workflows from work intake through closure and manages contractors and vendors for safety, technical capability, quality, delivery, performance, and cost. The role also manages staffing, employee development, budgets, forecasts, service contracts, overtime, materials, and cost improvements. The Head of Maintenance provides maintainability requirements for projects, commissioning, qualification, turnover, and equipment changes, and leads maintenance support for shutdowns, outages, start-ups, emergencies, and return-to-service. Its decision authority includes maintenance staffing and organization design, work allocation and performance management within approved budgets, maintenance work-management processes and priorities, and contractor or vendor selection within delegated authority. It is accountable for timely maintenance, calibration, and qualification; maintenance HSE controls and regulatory compliance; equipment reliability and maintenance-related APU downtime; maintenance budgets and contractor performance; project maintainability; inspection readiness; and effective risk escalation. Key interfaces include Operations; Quality, Validation and Metrology; HSE; Engineering, Projects and Automation; Procurement and Finance; and the Head of Site Engineering & Maintenance.
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 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 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, and performance management within approved budgets.
- Set maintenance work-management processes and priorities, and select contractors and vendors within delegated authority.
Benefits
- Health and wellbeing benefits, including high-quality healthcare and prevention and wellness programs.
- At least 14 weeks’ gender-neutral parental leave.
- Company employee benefit programs; further benefits information is available through the company.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
