GxP IT Consultant Empower (m/w/d)

Entourage; Berlin; Hybrid; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Entourage seeks a Waters Empower SME/Consultant to lead the Empower workstream in a regulated biotech setting in Germany.

You will own requirements translation, project setup and go-live support, ensuring GMP/GxP compliance, EU Annex 11, and data integrity throughout deployment. English is mandatory; German a plus.

Qualifikationen

• Hands-on experience with Waters Empower in pharma/biotech environments.
• Strong understanding of chromatography workflows and laboratory processes.
• Proven ability to implement and rollout Empower configurations.

Aufgaben

• Lead the application-side implementation, configuration and rollout of Waters Empower.
• Act as the central Empower SME throughout the project.
• Translate lab requirements into Empower configurations.

Kenntnisse

Professional English

GxP knowledge

Data Integrity

Tools

Waters Empower

Empower 3

Jobbeschreibung

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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