Stellenbeschreibung:

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.

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Stelleninformationen

  • Veröffentlichungsdatum:

    30 Jul 2026
  • Standort:

    Remote
  • Typ:

    Vollzeit
  • Arbeitsmodell:

    Vor Ort
  • Kategorie:

  • Erfahrung:

    2+ years
  • Arbeitsverhältnis:

    Angestellt

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