Head of Maintenance - Biologics
About The Position
The Head of Maintenance leads maintenance operations for a biologics manufacturing site in Framingham, Massachusetts. The role oversees preventive, corrective, and condition-based maintenance, calibration, and periodic qualification while maintaining schedule compliance, backlog control, resource alignment, and timely risk escalation. The position ensures maintenance work meets HSE, cGMP, data-integrity, permit, LOTO, energy-isolation, contractor-safety, and documentation requirements. It supports deviations, CAPAs, audits, and regulatory inspections, and improves equipment reliability and lifecycle performance to minimize maintenance-related manufacturing downtime. The role manages work processes from intake through closure, contractors and vendors, staffing and employee development, budgets and 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. The role works cross-functionally with 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.
- 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, condition-based maintenance, calibration, and periodic qualification.
- Maintain maintenance schedule compliance, control backlog, align resources, and escalate risks in a timely manner.
- Ensure maintenance activities meet 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.
- Make decisions on maintenance staffing, organization design, work allocation, performance management, work-management processes, and priorities within approved budgets and delegated authority.
- Maintain accountability for timely maintenance, calibration, and qualification; maintenance HSE controls and regulatory compliance; equipment reliability; maintenance-related APU downtime; maintenance budget; contractor performance; project maintainability; inspection readiness; and effective risk escalation.
Benefits
- At least 14 weeks’ gender-neutral parental leave.
- Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
- Thoughtful rewards package recognizing employee contributions.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
