Utilities Manager

Discover International; Brandenburg; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Discover International is seeking an Utilities & Mainten ance Readiness Manager to lead set-up, commissioning support and long-term ownership of clean and black utility systems at a biologics GMP site.

The role focuses on getting the site into operational readiness, establishing maintenance standards, vendor management, SOPs, spare parts, CMMS setup and handover from project to routine GMP operations. Longer term, it may broaden to a Plant Maintenance Manager role.

Qualifikationen

• Experience leading utilities and maintenance in pharma/biotech or regulated manufacturing.
• Strong knowledge of GMP utility systems including water, steam, gases and HVAC.
• Experience supporting site start-up, commissioning or handover into GMP operations.
• Ability to build maintenance systems from project environments to stable operations.
• Excellent cross-functional communication across Engineering, Quality, Production and EHS.
• German and English language skills strongly preferred.

Aufgaben

• Lead operational readiness for clean and black utilities across a GMP biologics site.
• Own utility systems including purified water, WFI, clean steam, gases, HVAC and electrical infra.
• Support commissioning, qualification, handover and start-up of utility systems.
• Develop maintenance strategies, PM plans, spare parts lists and CMMS structure.
• Coordinate vendors, service providers and internal project teams.
• Support interfaces with upstream, downstream, formulation and QC areas.
• Ensure systems support GMP manufacturing, cleaning, sterilisation and environmental control.
• Manage deviations, CAPAs, change controls and investigations related to utilities.
• Drive reliability, uptime, energy efficiency and lifecycle management.
• Collaborate with Engineering, CQV, Quality, Production, CQV and EHS teams.
• Plan future maintenance structure and contractor model for plant operations.

Kenntnisse

Utilities management

Maintenance leadership

Vendor management

CMMS

Cross-functional collaboration

GMP knowledge

Biologics manufacturing

Tools

CMMS (Computerized Maintenance Management System)

Jobbeschreibung

We are supporting a growing biopharmaceutical manufacturing organisation as they prepare a GMP site for operational readiness.

The business is looking for a Utilities & Maintenance Readiness Manager to lead the set-up, commissioning support and long-term ownership of clean and black utility systems across a biologics manufacturing facility.

This role will initially focus on bringing the site into operational readiness, including utility systems, maintenance standards, vendor management, SOPs, spare parts, CMMS set-up and handover from project phase into routine GMP operations. Longer term, the position can develop into a broader Maintenance Manager role for the plant.

Responsibilities

• Lead operational readiness for clean and black utilities across a GMP biologics manufacturing site.
• Own utility systems including purified water, WFI, clean steam, process gases, compressed air, HVAC, chilled water, heating systems, electrical infrastructure and waste systems.
• Support commissioning, qualification, handover and start-up of utility and facility systems.
• Build maintenance strategies, preventive maintenance plans, spare parts lists, SOPs and CMMS structures.
• Coordinate vendors, service providers, engineering partners and internal project teams.
• Support utility interfaces with upstream, downstream, formulation, filling, QC and cleanroom areas.
• Ensure systems are ready to support GMP manufacturing, cleaning, sterilisation and environmental control requirements.
• Manage troubleshooting, deviations, CAPAs, change controls and technical investigations related to utilities.
• Drive reliability, uptime, energy efficiency and lifecycle management of critical site systems.
• Work closely with Engineering, CQV, Quality, Production, MS&T, EHS and Automation teams.
• Develop the future maintenance structure, contractor model and technical support processes for routine plant operations.

Requirements

• Utilities, facilities or maintenance leadership experience within pharmaceutical, biotech, biologics or regulated manufacturing.
• Strong knowledge of GMP utility systems, including purified water, WFI, clean steam, clean gases, compressed air and HVAC.
• Experience supporting site start-up, operational readiness, commissioning, qualification or handover into GMP operations.
• Good understanding of black utilities such as chilled water, heating, electrical distribution, wastewater, plant steam and technical infrastructure.
• Experience working with biologics manufacturing equipment such as bioreactors, buffer/media preparation, chromatography skids, UF/DF systems, CIP/SIP systems, formulation areas or cleanrooms.
• Ability to build maintenance systems from an early-stage or project environment into a stable operational model.
• Strong knowledge of GMP documentation, deviations, CAPAs, change control, SOPs and audit readiness.
• Experience managing vendors, service contracts, spare parts, CMMS and preventive maintenance programmes.
• Strong cross-functional communication skills across Engineering, Quality, Production, CQV and EHS.
• German and English language skills strongly preferred.