Waters Empower SME / Consultant (m/w/d) – Pharma & Biotech | Start ASAP
For our Entourage consultant team, we are looking for an experienced Waters Empower SME who can join us at short notice and take a key role in the implementation and rollout of Waters Empower within a regulated biotech environment.
You will take ownership of the Empower application workstream and work closely with Analytical/CMC, Quality, IT, CSV specialists and System Administration to drive the system from requirements and configuration through to successful rollout and operational readiness.
Your responsibilities:
- Lead the application-side implementation, configuration and rollout of Waters Empower
- Act as the central Empower SME throughout the implementation
- Translate analytical laboratory requirements and workflows into effective Empower configurations
- Configure projects, users, privileges, system policies, custom fields and calculations
- Support the setup and integration of analytical instruments and laboratory workflows
- Provide Empower expertise and support the dedicated CSV workstream with technical and functional input
- Ensure the application setup supports GxP/GMP, EU Annex 11, 21 CFR Part 11 and Data Integrity requirements
- Support testing, troubleshooting, change control, user training and Go-Live
- Coordinate closely with Analytical/CMC, QA, IT, CSV specialists, System Administration and vendors
Your background:
- 3+ years of hands-on Waters Empower experience, ideally Empower 3 / Enterprise
- Proven experience with Empower implementation and rollout in Pharma or Biotech
- Strong understanding of chromatography systems and analytical laboratory workflows
- Hands-on experience with Empower configuration, including projects, privileges, custom fields and calculations
- Solid knowledge of GMP/GxP, EU Annex 11, 21 CFR Part 11 and Data Integrity
- Good understanding of CSV / GAMP 5 and experience supporting validation activities
- Ability to independently take ownership of an Empower application workstream
- Professional English is mandatory – German is a plus
Germany / Hybrid – onsite presence depending on project needs
Start: ASAP / short-notice availability strongly preferred
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