Clean Room Engineer

West Pharmaceutical Services, Inc; Horsens; On-site; DKK 554,000 - 630,000; Full time

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

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life‑saving and life‑enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

We are looking for an experienced professional to support and optimize activities across Clean Utility (CU), Environmental Monitoring Systems (EMS), Warehouse Monitoring Systems, and clean room infrastructure. The role includes responsibility for quality, compliance, reporting, qualification, and technical support activities, as well as close collaboration with global and cross-functional teams to support site operations and continuous improvement.

Essential Duties And Responsibilities

• Provide production support and drive process optimization across Clean Utility (CU), Environmental Monitoring Systems (EMS), Warehouse Monitoring Systems (WMS), and clean room infrastructure.
• Be the 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 across these areas, including recertification, clean room qualifications, risk assessments, audits, complaint support, and periodic reporting.
• Maintain the control list and certificate traceability for all product-contact components used in WFI, clean steam, and washer systems.
• Train Site Maintenance Technicians in Westar Lined Seals processes, including VCD, CSG, WFI Loop, and Pharma Washers.
• Update SOPs and SDs to simplify and optimize usability.
• Improve quality through systematic handling of deviations, CAPAs, and A3s.
• Drive continuous improvement in relation to quality, safety, cost, cleaning, validation, capacity, and bottleneck management.
• Work with Maintenance and Quality Engineers to ensure the PM program remains up to date.
• Participate in projects as a subject matter expert.

Education

• A bachelor’s degree in Engineering is required.
• Marine Engineer education is preferred.

Work Experience

• Minimum 5 years of experience in the pharmaceutical industry.
• Understanding of project management principles is preferred.

Preferred Knowledge, Skills And Abilities

• General knowledge of safety regulations, workflows, production equipment, industrial techniques, manufacturing, and process automation.
• Maintain awareness of state-of-the-art technology as it applies to the industry and participate in educational programs relevant to process projects.
• Very good knowledge of SAP and Microsoft Office applications.
• Fluency in Danish and English.
• Experience working with ISO 9001, FDA, and cGMP standards is required.
• Ability to work independently, systematically, and analytically.
• Understanding of and experience with Lean manufacturing principles.
• Ability to write routine reports, correspondence, and process documentation.
• Excellent organizational and communication skills.

License and Certifications

Manufacturing and/or Six Sigma Green Belt certification is preferred.

Travel Requirements

5%: Up to 13 business days per year

Pay Transparency

The annual base salary range for this position is kr553,700.00 - kr630,400.00. Total target compensation is determined using objective and gender‑neutral criteria, including relevant experience, qualifications, skills, market benchmarks, geographic location, and the scope and responsibilities of the role.

This position may be eligible for variable compensation and other incentive programs in accordance with the terms of the applicable plans within the country of employment. In addition, team members are eligible to participate in the company’s benefits and total rewards programs applicable to their location and employment status.

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post‑offer background screening.