Head of Engineering & Maintenance - Lyophilisation

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

**Job Title:** Head of Engineering & Maintenance - Lyophilisation* **Location:** Waterford Ireland* **Job Type:** Permanent, Full-time* **Working Arrangement:** 5 Days On-Site **About the role** Reporting directly to the Head of Site Engineering & Maintenance and as a leader for Sanofi, you will play an integral role within the Lyophilisation Autonomous Production Unit management team, ensuring reliable supply of lyophilised vial products for our rare disease patients globally. Ready to get started? Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. **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 people’s lives.*Main responsibilities* * Lead all assigned Lyophilisation engineering & maintenance activities to ensure that objectives are met across batch filling & Lyophilisation (Loading/unloading), batch turnaround time, batch release cycle time, annual shutdown planning, project/program implementation, CI plans, etc.* Ensure all activities are undertaken in compliance with cGMP (FDA 21 CFR Part 211, EU GMP Annex 1), Safety and Engineering Standards* Timely execution of maintenance strategy (Corrective, Preventative, Predictive Maintenance* Ensure compliance across maintenance KPIs (Work orders, PMs, MTBF/MTTR, permits, LOTO, etc)* Ensure equipment reliability strategy is deployed and sufficient for cGMP* Ensure all employees, for which they are responsible, are trained against SOPs and GMP requirements relevant to their job* Ensure procedures are correctly defined and followed* Monitor the level of GMP compliance in their area on an on-going basis through audit, deviations and GMP document reviews* Develop and improve the effectiveness of training on a regular basis* Develop and lead a continuous improvement program that will result in savings to COGs* Manage maintenance spend (Budget, headcount, parts, services)**About You** *Essential requirements:** Higher level Degree in Third level Engineering qualification or equivalent* Significant experience as an Engineering & Maintenance Manager/ other Management role* Demonstrable experience of pharmaceutical manufacturing environment* Engineering & Maintenance standards applied across the life cycle asset management* Technical knowledge of relevant sterile filling and lyophilisation technology* Detailed knowledge of cGMP regulations* Good problem solving and analytical skills* Effective facilitator & Excellent interpersonal skills* Influences site KPI’s and drives area improvement* Full understanding of Health & Safety and legal requirements for the safe operation of the team*It would be advantageous to have (not essential):** Engineering & Maintenance technical expertise in sterile filling and lyophilisation* Engineering & Maintenance management experience in a pharmaceutical environment* Engineering & Maintenance proven track record in working in a highly regulated industry**Why choose us?*** Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.* Transform lives worldwide by delivering life-changing treatments anywhere, anytime.* Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride.* Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.