Biologics Maintenance & Reliability Leader

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

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.