Sunday, October 26, 2025

Job Description

Blackfield Associates are currently partnered with a global pharmaceutical manufacturer to support their search for a Clean Utilities Lead to join their project based in Kalundborg on an initial 12-month contract.Key ResponsibilitiesLead the design, installation, and commissioning of clean utility systems including WFI, PW, clean steam, process air, and gases.Ensure clean utility systems meet GMP requirements and engineering standards.Coordinate with design teams, contractors, and internal stakeholders to ensure timely and compliant delivery.Review and approve technical documentation including P&IDs, specifications, and validation protocols.Support troubleshooting and resolution of clean utility issues during construction and commissioning.Oversee qualification activities and ensure systems are ready for regulatory inspection and operational use.Interface with other disciplines (HVAC, process, automation) to ensure seamless integration.Provide technical leadership and mentoring to junior engineers and site teams.Experience RequiredSufficient years of experience in clean utility engineering in a lead role on large-scale pharmaceutical or biotech projects.Strong knowledge of clean utility systems in GMP environments.Experience with commissioning, qualification, and validation of clean utilities.Familiarity with Danish and EU regulatory standards and engineering practices.Degree in Mechanical, Chemical, or Process Engineering; professional certification is a plus.Fluent in English; Danish language skills are advantageous.

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