jobid=A.0.0252
Do you want to contribute directly to the production of high-quality medicines that reach over 140 countries, positively impacting global healthcare?
NES Fircroft is seeking a highly experienced Senior Utilities Engineer to support the startup, qualification, and ongoing compliance of clean utility systems within a sterile GMP setting. This role is critical in ensuring that systems such as WFI, Purified Water, Clean Steam, HVAC, and compressed gases meet current regulatory standards and operate reliably.
Length: 12 months (possibility of extension)
- Lead commissioning and qualification (IQ/OQ/PQ) of clean utility systems per ASTM E2500 and GAMP.
- Manage FAT/SAT and author URS, FS, and DDS documentation.
- Ensure validated status and maintenance of WFI, PW, and Clean Steam systems.
- Review P&IDs, layouts, and isometrics during early project phases for compliance.
- Assess technical documentation for regulatory and operational alignment.
- Support inspections (e.g., IGJ) and ensure utility system readiness.
- Lead or assist in investigations and CAPA implementation.
- Design sampling/testing strategies with defined alert/action limits.
- Develop SOPs, maintenance plans, and long-term reliability strategies.
- Maintain audit-ready technical documentation.
- Drive improvements in compliance, energy efficiency, and system performance.
Candidate Profile:
- At least 4 years of experience in pharmaceutical or biotech GMP environments.
- Proven expertise in startup and qualification of WFI, PW, and Clean Steam systems.
- Strong understanding of regulatory expectations for clean utilities (IGJ, FDA, EMA).
- Experience supporting regulatory inspections and managing utility-related compliance activities.
- Strategic thinker with the ability to structure and lead complex technical programs.
