Bachelor's degree in engineering, maintenance management, life sciences, or related field.
7+ years of relevant experience, including 3+ years leading technical teams in regulated manufacturing.
Experience in maintenance execution, reliability, calibration, contractor management, budgeting, and shutdown support.
Knowledge of cGMP, data integrity, deviations, CAPAs, CMMS/EAM, safe-work permits, and LOTO.
Strong communication, decision-making, and cross-functional leadership skills.
Responsibilities
Lead preventive, corrective, and condition-based maintenance activities.
Ensure compliance with HSE, cGMP, and regulatory requirements during maintenance.
Enhance asset reliability through failure analysis and root cause analysis.
Manage maintenance workflows and contractor performance effectively.
Oversee staffing, budgets, and cost improvements while ensuring safety and compliance.
Provide maintainability requirements for projects and lead maintenance during shutdowns.
Benefits
Participation in employee benefit programs.
Opportunities for professional development and training.
Full Job Description
Job Title: Head of Maintenance - Biologics
Location: Framingham, MA
Main Responsibilities
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.
Decision Authority
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.
Accountable For
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.
Informed Of
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.
Key Interfaces
Operations; Quality, Validation and Metrology; HSE; Engineering, Projects and Automation; Procurement and Finance; and the Head of Site Engineering & Maintenance.
About You
Basic Qualifications
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.
Preferred Qualifications
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.
The salary range for this position is: $148,500.00 - $214,500.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
About Sanofi
Sanofi is a global pharmaceutical company that specializes in the research, development, and manufacturing of prescription drugs and vaccines. The company operates in over 170 countries and has a diverse portfolio of products that includes treatments for diabetes, cancer, cardiovascular disease, and rare diseases. Sanofi is committed to improving global health and has a strong focus on innovation and sustainability. The company has received numerous awards for its research and development efforts and is recognized as a leader in the pharmaceutical industry.
