PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors.
With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational clients.
This focus, and our people's experience in delivering consistent quality results for our clients over the past 20 years has been key to our success to date.
We are currently looking for CQV Engineer-FAT Readiness to join us on a permanent basis to help us deliver various projects in the Life Sciences Industry.
This role requires travel around Europe for various FATs
Key Attributes/Responsibilities:
- Be based primarily at supplier facilities during design, fabrication, FAT and pre-shipment phases, with travel to other vendor locations as required.
- Coordinate supplier C&Q activities in alignment with the Validation Master Plan (VMP), C&Q Execution Plan (CQEP) and Quality by Design (QbD) principles.
- Act as the key interface between suppliers and AZ stakeholders, including C&Q Leads, Quality, SMEs and System Owners.
- Manage supplier C&Q deliverables, including VTOPs, CTOPs, ITPs, FAT/SAT protocols and associated qualification documentation.
- Drive supplier readiness for DQ, Pre-FAT and FAT, ensuring documentation, protocols and systems are approved before execution.
- Review supplier design documentation, including P&IDs, specifications and control strategies, for compliance with URS, GMP and qualification requirements.
- Ensure adherence to regulatory, quality, SHE and Good Documentation Practice (GDP) standards, maintaining audit-ready documentation.
- Oversee fabrication, construction testing and documentation progress, identifying design deviations, quality risks and compliance gaps.
- Monitor project risks, changes, issues and performance, providing regular progress reports and escalating deviations with corrective actions.
- Own supplier C&Q schedules, tracking milestones, commitments and deliverables to ensure execution within approved timelines and quality requirements.
PES International operates as an equal-opportunity employer.
No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills.
We confirm that we are happy to accept applications from persons of any background for this role.
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Kontaktdaten:
EFOR (formerly Process Engineering Specialists) Recruiting-Team
