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Clean Room Engineer

West Pharmaceutical Services · Horsens

New
Senior 553,700 - 630,400 DKK/year 🇬🇧 English
SAP Microsoft Office ISO 9001 FDA cGMP Lean manufacturing Six Sigma

Job description

About the role

West Pharmaceutical Services is looking for an experienced Clean Room Engineer in Horsens to support and optimise activities across Clean Utility (CU), Environmental Monitoring Systems (EMS), Warehouse Monitoring Systems (WMS) and clean room infrastructure. The role covers quality, compliance, reporting, qualification and technical support, working closely with global and cross-functional teams.

Key responsibilities

  • Provide production support and drive process optimisation across CU, EMS, WMS and clean room infrastructure.
  • Act as owner and approval authority for clean room infrastructure, EMS, WMS and Westar water plant equipment and processes, including WFI and pure steam production.
  • Lead quality and compliance activities such as recertification, clean room qualifications, risk assessments, audits, complaint support and periodic reporting.
  • Maintain the control list and certificate traceability for product-contact components used in WFI, clean steam and washer systems.
  • Train Site Maintenance Technicians in Westar Lined Seals processes (VCD, CSG, WFI Loop, Pharma Washers).
  • Update SOPs and SDs to simplify and optimise usability, and handle deviations, CAPAs and A3s to improve quality.
  • Drive continuous improvement in quality, safety, cost, cleaning, validation, capacity and bottleneck management, and work with Maintenance and Quality Engineers on the PM programme.
  • Take part in projects as a subject matter expert.

Required profile

  • Bachelor's degree in Engineering; Marine Engineer education preferred.
  • Minimum 5 years of experience in the pharmaceutical industry.
  • Fluency in Danish and English.
  • Experience with ISO 9001, FDA and cGMP standards is required.
  • Manufacturing or Six Sigma Green Belt certification preferred.

Required skills

  • Very good knowledge of SAP and Microsoft Office.
  • Lean manufacturing principles and understanding of project management principles preferred.
  • Ability to write routine reports, correspondence and process documentation.

What we offer

  • Annual base salary range of DKK 553,700 to DKK 630,400, with possible variable compensation and incentive programmes.
  • Up to 13 business days of travel per year.
  • Benefits and total rewards programmes applicable to the location and employment status.

Questions fréquentes

Le salaire proposé pour ce poste est de 554-630k DKK par an. Le détail figure dans l'annonce.
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Source : ats:successfactors

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Published 6 hours ago

Expires 1 month from now

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West Pharmaceutical Services

Horsens