Head of Engineering & Maintenance - Lyophilisation

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 LyophilisationAutonomous Production Unit management team, ensuring reliable supply of lyophilised vial products for our rare disease patients globally.

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 Lyophilisationengineering & 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.