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 Quality Control SME- Empower to join us on a long term project to help us deliver various projects in the Life Sciences Industry.

Key Attributes/Responsibilities:

• Serve as the Subject Matter Expert (SME) for Waters Empower Chromatography Data System (CDS) within GMP laboratory environments.
• Lead or support computerized system validation (CSV) activities for Empower, including URS, risk assessment, IQ/OQ/PQ, and validation documentation.
• Configure, administer, and maintain Empower projects, user roles, audit trails, and data integrity controls in compliance with GxP and ALCOA+ principles.
• Provide technical support and troubleshooting for chromatography systems integrated with Empower.
• Support qualification and lifecycle management of analytical instruments connected to Empower.
• Experience with Waters HPLC/UPLC systems is required; experience with Thermo Scientific LCs, Agilent GC-HS, Sciex CE, or ProteinSimple iCIEF is an advantage.
• Collaborate with QA, QC laboratories, and IT to ensure regulatory compliance with FDA 21 CFR Part 11 and EU Annex 11.
• Support audits, data integrity reviews, and periodic system assessments.
• Prepare and review validation documentation and provide SME guidance during regulatory inspections.

If you'd like to find out about this opportunity, please forward your CV to Nelson Anthony ([email protected]).

If you would like to find out about the latest Jobs and Projects we are involved in then do follow us on LinkedIn: https://www.linkedin.com/company/processengineeringspecialists/mycompany/

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 and we confirm that we are happy to accept applications from persons of any background for this role.