Senior Clean Room & GMP Compliance Engineer

West Pharmaceutical Services, Inc

Horsens

On-site

DKK 554,000 - 630,000

Full time

2 days ago
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Job summary

West Pharmaceutical Services, Inc. is seeking an experienced professional to support and optimize quality, compliance, and site operations across Clean Utility, Environmental Monitoring Systems, and related infrastructure.

You will collaborate with global cross-functional teams to drive process improvements and maintain regulatory readiness. Requirements include a bachelor’s degree in Engineering (Marine Engineer preferred), minimum 5 years in pharma, strong knowledge of SAP and MS Office, and

Qualifications

  • Minimum 5 years of experience in the pharmaceutical industry.
  • Understanding of project management principles is preferred.
  • Bachelor’s degree in Engineering is required; Marine Engineer education is preferred.
  • Very good knowledge of SAP and Microsoft Office applications.
  • Fluency in Danish and English.
  • Experience with ISO 9001, FDA, and cGMP standards is required.
  • Ability to work independently and analytically.

Responsibilities

  • Provide production support and drive quality compliance across CU, EMS, WMS, and clean room infrastructure.
  • Lead qualification and recertification activities and risk assessments.
  • Maintain traceability for product-contact components in WFI and clean steam systems.
  • Train technicians on Westar Lined Seals processes and related procedures.
  • Update SOPs and SDs to improve usability and accuracy.
  • Support PM program with Maintenance and Quality Engineers and drive continuous improvement.

Skills

SAP
Microsoft Office
Lean manufacturing
ISO 9001/FDA/cGMP knowledge
Danish language
English language
Project management
Six Sigma Green Belt

Education

Bachelor's degree in Engineering
Marine Engineer education

Job description

West Pharmaceutical Services, Inc. is seeking an experienced professional to support and optimize quality, compliance, and site operations across Clean Utility, Environmental Monitoring Systems, and related infrastructure.

You will collaborate with global cross-functional teams to drive process improvements and maintain regulatory readiness. Requirements include a bachelor’s degree in Engineering (Marine Engineer preferred), minimum 5 years in pharma, strong knowledge of SAP and MS Office, and

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