LIMS Consultant (m/w/d)

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

Zusammenfassung

Entourage seeks an experienced LIMS SME/Consultant to join our team in Germany on short notice. You will own the LIMS application workstream, collaborating with laboratory, QA, IT, CSV specialists and vendors to drive configuration, validation and rollout in a regulated biotech environment.

The role requires 3+ years of hands-on LIMS experience, familiarity with LabWare, LabVantage or SampleManager, and a strong grasp of GMP/GxP and Data Integrity.

Qualifikationen

• 3+ years hands-on LIMS implementation in Pharma/Biotech
• Experience with LabWare, LabVantage, SampleManager or similar
• Understanding of GMP/GxP, EU Annex 11 and Data Integrity
• Knowledge of CSV/GAMP5 and validation activities
• Ability to own a LIMS application workstream
• Professional English mandatory; German a plus

Aufgaben

• Lead the application-side implementation, configuration and rollout of the LIMS
• Act as the central LIMS SME during the implementation
• Translate laboratory requirements into LIMS workflows and configurations
• Configure workflows, roles, permissions and system functionalities
• Set up and maintain LIMS master data (methods, specifications, instruments, sampling plans, tests, reporting templates)
• Provide LIMS expertise and support the CSV workstream with input
• Ensure the setup supports GMP/GxP, EU Annex 11, 21 CFR Part 11 and Data Integrity
• Support testing, troubleshooting, change control, user training and Go-Live
• Coordinate with laboratory teams, QA, IT, CSV specialists, System Administration and vendors

Kenntnisse

LIMS implementation

GxP/GMP awareness

CSV/GAMP5

Lab workflows

Data integrity

Project ownership

Cross-functional coordination

Communication

Regulatory compliance

QA collaboration

Ausbildung

Bachelor's degree in Life Sciences

Tools

LabWare

LabVantage

SampleManager

CSV tools

Jobbeschreibung

LIMS SME / Consultant (m/w/d) – Pharma & Biotech | Start ASAP

For our Entourage consultant team, we are looking for an experienced LIMS SME / Consultant who can join us at short notice and take a key role in the implementation and rollout of a LIMS within a regulated biotech environment.

You will take ownership of the LIMS application workstream and work closely with laboratory teams, 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 the LIMS
• Act as the central LIMS SME throughout the implementation
• Translate laboratory requirements and processes into effective LIMS workflows and configurations
• Configure workflows, roles, permissions and system functionalities
• Set up and maintain LIMS master data, including methods, specifications, instruments, sampling plans, tests and reporting templates
• Provide LIMS expertise and support the dedicated CSV workstream with functional and technical 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 laboratory teams, QA, IT, CSV specialists, System Administration and vendors

Your background:

• 3+ years of hands-on experience with LIMS implementation and configuration in Pharma, Biotech or another regulated Life Sciences environment
• Strong hands-on knowledge of established LIMS platforms such as LabWare, LabVantage, SampleManager or comparable systems
• Strong understanding of QC/analytical laboratory processes and workflows
• Hands-on experience with LIMS configuration, workflows and master data
• 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 a LIMS 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

#LIMS #LaboratoryInformatics #Pharma #Biotech #GMP #GxP #CSV #GAMP5 #DataIntegrity #DigitalLab #Consulting #Entourage