Senior Utilities Engineer

1 week geleden

Leiden, Zuid-Holland, Nederland Planet Pharma Voltijd

We're Hiring: Senior Utilities Engineer – Sterile GMP Environment 16 Month Contract

Are you a seasoned Utilities Engineer with a passion for clean utility systems and GMP compliance? We're looking for a strategic and hands-on expert to lead the qualification and operation of critical systems including WFI, PW, Clean Steam, HVAC, and compressed gases in a sterile pharmaceutical setting.

Key Responsibilities:

  • Lead commissioning and qualification (IQ/OQ/PQ) of clean utilities per ASTM E2500 and GAMP.
  • Oversee FAT/SAT, URS, FS, and DDS development.
  • Ensure validated status and maintenance of utility systems.
  • Drive compliance with IGJ, FDA, EMA regulations.
  • Support inspections and lead CAPA investigations.
  • Develop SOPs, sampling strategies, and maintenance plans.
  • Champion system reliability, energy efficiency, and sustainability.

What We're Looking For:

  • 5–10+ years in GMP pharmaceutical/biotech environments.
  • Proven experience with WFI/PW/Clean Steam systems in startup settings.
  • Deep knowledge of regulatory expectations and inspection readiness.
  • Strong strategic thinking and organizational skills.

This is a high-impact role for someone ready to shape utility systems from the ground up and ensure they meet the highest standards of compliance and performance.

Location: Leiden

Contract Role

Interested or know someone who fits the bill? Let's connect

UtilitiesEngineering #GMP #PharmaJobs #CleanUtilities #EngineeringLeadership #Validation #Compliance #PharmaceuticalEngineering #LeidenJobs

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

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