Senior Utilities Engineer

  • Leiden
  • 4000.00 - 6500.00
  • 32-40 hours
  • Bachelor degree

Client

Our client is a leading consulting and engineering firm in pharma, food and chemistry.

Requirements

  • 5-10+ years in pharmaceutical or biotech GMP environment.
  • Direct experience in bringing WFI/PW/clean steam systems online in a startup setting.
  • Knowledgeable in design, qualification, and regulatory expectations of clean utilities.
Experience supporting regulatory inspections related to utility systems

What do you get?

  • Pension entitlement as from day one
  • Collective WGA / WIA insurance
  • NBBU / ABU collective labor agreement
  • 25 holidays days
  • 8,33% holiday allowance
  • 100% payment in case of illness after one waiting day
  • Travel allowance

Duties

· Hands-on execution and oversight of commissioning activities and qualification phases (IQ, OQ, PQ) for clean utility systems per ASTM E2500 and GAMP principles.
· Lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT), and development of User Requirements Specifications (URS), Functional Specifications (FS), and Detailed Design Specifications (DDS).
· Responsible for (timely) maintenance of utilities, coordinate with third-party and vendors to ensure utilities are up and running and keep validated status.
· Responsible to bring and keeping WFI, Purified Water, and Clean Steam systems online within GMP conditions.
· Engage early in project lifecycle from design review of P&IDs, layouts, and isometric drawings through final system handover.
  • Critically evaluate design documentation to assure compliance and operational reliability.
  • Support and prepare for pharmaceutical inspections.
  • Provide detailed knowledge of regulatory expectations related to design, qualification, and operational aspects of utilities.
  • Lead or assist investigations related to system excursions and CAPA implementation during inspections.
  • Design sampling and testing strategies, including location selection and sampling frequency for PW, WFI, and Clean Steam during startup, validation, and routine operation.
  • Define alert and action limits and lead investigations of excursions to ensure continuous compliance with GMP standards.
  • Develop a maintenance strategy, robust SOPs, maintenance plans,
  • Ensure the technical documentation for utilities is complete and controlled
  • Drive process improvements focusing on system reliability, compliance, energy efficiency, and sustainability.

TAGCLOUD

Sander Pupella

Interested

Send your resume to sander@tailorminds.com referring to job id (1966)

More information?

Please contact Sander Pupella working at our office in Zoetermeer, phone number +31 6-13140754

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