Head of Engineering & Maintenance - Lyophilisation

Sanofi; Waterford; On-site; EUR 84,000 - 112,000; Full time

Job summary

Sanofi Waterford is seeking a Head of Engineering & Maintenance for Lyophilisation to lead the Lyophilisation Autonomous Production Unit, ensuring a reliable supply of lyophilised vial products for rare disease patients worldwide. This permanent, on-site role sits within Manufacturing & Supply and collaborates with global teams to deliver at scale.

You will drive the maintenance strategy, ensure cGMP compliance, manage budget and headcount, and lead continuous improvement.

Qualifications

• Higher level degree in engineering or equivalent.
• Significant experience as Engineering & Maintenance Manager or similar.
• Experience in pharmaceutical manufacturing environment.
• Knowledge of cGMP regulations.
• Strong problem solving and analytical abilities.

Responsibilities

• Lead Lyophilisation engineering & maintenance activities across batch filling and loading/unloading.
• Ensure activities comply with cGMP, safety and engineering standards.
• Execute maintenance strategy (Corrective, Preventive, Predictive).
• Maintain equipment reliability for cGMP.
• Train employees on SOPs and GMP requirements.
• Define and follow procedures; monitor GMP compliance.
• Develop training programs and continuous improvement initiatives.
• Manage maintenance spend (budget, headcount, parts, services).

Skills

Problem solving

Analytical skills

Interpersonal skills

KPI awareness

Safety mindset

Education

Engineering qualification (Higher level)

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

• 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.

#LI-EUR

Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! The salary range for this position is :€84 000,00 - €112 000 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs. 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.