Head of Maintenance - Biologics

BioSpace; Framingham (MA); On-site; USD 180,000 - 230,000; Full time

Job summary

Sanofi in Framingham, MA is seeking a Head of Maintenance - Biologics to lead maintenance execution, reliability, and contractor management within a regulated biopharma setting. This role focuses on safety, compliance, and delivering uptime for critical biologics manufacturing assets.

You will direct budgets, staffing, and shutdown support while partnering with Operations, Quality, and Engineering to ensure inspection readiness and continuous improvement.

Qualifications

• 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.
• Working 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, condition-based maintenance, calibration, and qualification.
• Ensure compliance with HSE, cGMP, data integrity, permits, LOTO, and audits.
• Improve asset reliability and lifecycle performance via failure analysis and monitoring.
• Manage maintenance workflows, contractors, and vendors for safety and cost.
• Oversee staffing, budgets, contracts, and cost improvements without compromising safety.
• Provide maintainability input for projects and support shutdowns and startups.

Skills

Leadership

Regulated manufacturing

Maintenance execution

CMMS/EAM

cGMP

Data integrity

LOTO

Budgeting

Contractor management

Shutdown support

Education

Bachelor's degree in engineering or related field

PE/CMRP/CRL/PMP/CEM or Lean Six Sigma (preferred)

Tools

CMMS/EAM

Job description

Job Title: Head of Maintenance - Biologics

Location: Framingham, MA

About The Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

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 Rights

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

• Bachelors 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.

Why choose us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.

Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.

Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale

Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SG #vhd

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.