We are looking for a skilled with Empower expertise to join our team on a long-term project supporting diverse Life Sciences initiatives.
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.
Requirements / Qualifications
- Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biotechnology, or a related scientific discipline.
- Minimum 3-5+ years of hands-on experience with Waters Empower Chromatography Data System (CDS) in a GMP-regulated environment.
- Strong knowledge of computerized system validation (CSV) processes, including URS, risk assessments, IQ/OQ/PQ, and lifecycle documentation.
- Proven experience in Empower system administration, including project setup, user management, audit trails, and data integrity controls.
- Solid understanding of GxP regulations, ALCOA+ principles, and data integrity requirements.
- Experience supporting and troubleshooting chromatography systems (HPLC/UPLC) integrated with Empower.
- Familiarity with instrument qualification and lifecycle management for analytical laboratory systems.
- Working knowledge of regulatory requirements such as FDA 21 CFR Part 11 and EU Annex 11.
- Experience supporting audits, inspections, and data integrity reviews.
- Strong documentation skills with the ability to prepare, review, and manage validation documents.
