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.
Client
Our client is a leading consulting and engineering firm in pharma, food and chemistry. They participate in interesting projects in the pharmaceutical industry. They do this by providing support to clients on challenging and varied projects. Usually with the opportunity for personal development in addition to your contribution.
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.
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.
