On-Site Lyophilisation Engineering & Maintenance Leader

Sanofi Group; Waterford; Hybrid; EUR 120,000 - 150,000; Full time

Job summary

Sanofi Waterford is seeking a Head of Engineering & Maintenance for the Lyophilisation unit. You will lead engineering & maintenance activities to ensure reliable supply of lyophilised vial products globally, while maintaining compliance with cGMP and safety standards.

You will drive continuous improvement, manage budgets and headcount, and ensure staff training on GMP requirements. This is a senior, on-site leadership role within a highly regulated biopharma setting.

Qualifications

• Higher-level engineering degree or equivalent.
• Significant experience as an engineering & maintenance manager or similar.
• Pharmaceutical manufacturing environment experience.
• Strong knowledge of lyophilisation and sterile filling technologies.
• Solid understanding of cGMP regulations and safety standards.

Responsibilities

• Lead Lyophilisation engineering & maintenance activities across loading/unloading, batch turnaround, release cycles, and shutdown planning.
• Ensure all activities comply with cGMP, FDA/EU regulations, and safety standards.
• Deliver timely maintenance strategy (corrective, preventive, predictive).
• Maintain and improve maintenance KPIs (work orders, PMs, MTBF/MTTR, permits, LOTO).
• Deploy equipment reliability strategies for regulatory compliance.
• Ensure staff are trained on SOPs and GMP requirements; enforce procedures.

Skills

Engineering management

Problem solving

Interpersonal skills

KPI improvement

Health & safety

cGMP compliance

Lyophilisation tech

Leadership

Education

Engineering degree

Job description

Sanofi Waterford is seeking a Head of Engineering & Maintenance for the Lyophilisation unit. You will lead engineering & maintenance activities to ensure reliable supply of lyophilised vial products globally, while maintaining compliance with cGMP and safety standards.

You will drive continuous improvement, manage budgets and headcount, and ensure staff training on GMP requirements. This is a senior, on-site leadership role within a highly regulated biopharma setting.