Head of Maintenance - Biologics

(5102) Genz. Therap Product LP; Framingham (MA); On-site; USD 149,000 - 215,000; Full time

Benefits offered by this job

High-quality healthcare

14 weeks parental leave

Wellness programs

Job summary

Sanofi Group in Framingham, MA, seeks a Head of Maintenance for Biologics to lead maintenance execution, safety, and reliability programs across a regulated manufacturing environment. You will drive calibration, qualification, and contractor oversight while partnering with quality and engineering teams to ensure compliant operations.

The role emphasizes asset lifecycle optimization, budgeting, and a strong focus on cGMP, data integrity, and regulatory readiness.

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.
• 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, and calibration maintenance and periodic qualification.
• Ensure schedule compliance, backlog control, and risk escalation.
• Ensure activities meet HSE, cGMP, data integrity, permits, LOTO, and documentation.
• Support deviations, CAPAs, audits, and regulatory inspections.
• Improve asset reliability via failure analysis and condition monitoring.
• Handle work intake, contractor/vendor management, and safety performance.
• Manage staffing, budgets, contracts, overtime, and cost improvements.
• Provide maintainability input for projects, commissioning, and turnover.
• Lead shutdowns, outages, start-ups, emergencies, and return-to-service.
• Make staffing and budget decisions within approved budgets.

Skills

Maintenance leadership

Contractor management

Budgeting

CMMS/EAM

Education

Bachelor's degree in engineering/maintenance life sciences

Tools

CMMS/EAM

LOTO

Job description

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. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world.

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

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.

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 it’s 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.

Benefits and Perks

• high-quality healthcare
• prevention and wellness programs
• at least 14 weeks' gender-neutral parental leave

EEO / Diversity Statement

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affiantive 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.

Sanofi US endeavours to make our career center accessible to any and all users. Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

Salary

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 (duplicate)

We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.