Clean Utilities Lead

An exciting opportunity to join an international engineering organisation delivering complex pharmaceutical and biotech projects across Europe and globally.

We are looking for a Clean Utilities Lead to support sterile manufacturing projects in Germany, with a focus on aseptic fill-finish, vial production, GMP utilities, cleanrooms and process equipment interfaces . This role is suited to someone who can lead clean utilities design and delivery, coordinate technical interfaces, and support project execution across design, construction, commissioning and CQV phases.

Responsibilities

• Lead clean utilities scope for sterile fill-finish and aseptic manufacturing projects.
• Support design and delivery of WFI, purified water, clean steam, process gases, compressed air, CIP/SIP and related GMP utility systems.
• Coordinate technical interfaces with process equipment, HVAC, cleanrooms, automation, CQV and construction teams.
• Review P&IDs, URS, layouts, specifications, vendor packages and technical deliverables.
• Support integration of utilities with vial filling lines, isolators/RABS, washers, depyrogenation tunnels, lyophilisers, cappers, inspection and packaging systems.
• Manage technical queries, design reviews, vendor coordination, risks, changes and project actions.
• Ensure clean utilities design and installation align with GMP, Annex 1, hygienic design, EHS, quality and client requirements.
• Support FAT/SAT, installation, commissioning, qualification readiness and handover.
• Work closely with EPCMV teams, equipment vendors, contractors and client stakeholders.
• Provide clear technical updates and support issue resolution throughout project delivery.

Requirements

• Clean utilities engineering experience within pharmaceutical, biotech or life sciences projects.
• Experience supporting sterile, aseptic, fill-finish, vial or GMP manufacturing facilities.
• Strong knowledge of WFI, purified water, clean steam, process gases, compressed air, CIP/SIP and distribution systems.
• Good understanding of P&IDs, URS, specifications, layouts, vendor documentation and GMP utility design.
• Understanding of cleanroom environments, contamination control, hygienic design and classified areas.
• Experience coordinating with process, HVAC, automation, CQV, construction and vendor teams.
• Ability to support projects across design, construction, commissioning and qualification interfaces.
• Strong technical coordination, documentation and stakeholder management skills.
• Fluent German and English required.
• Willingness to travel for project requirements.