LIMS Consultant, Validation Expert

Responsibilities

• Advise clients on the implementation, optimization and validation of LIMS solutions in regulated environments
• Coordinate and carry out LIMS lifecycle activities while ensuring compliance with regulatory requirements (e.g. GAMP 5, EU GMP, GLP and FDA)
• Support system selection as well as requirements engineering, risk management and test management
• Plan, coordinate and execute (re-)validation activities as part of Computer System Validation (CSV)
• Support integration of laboratory instruments and review audit trails and data integrity
• Collaborate with clients, business units and system vendors to ensure successful project delivery
• Actively contribute to the expansion and further development of the consulting practice for LIMS and lab informatics

Requirements

• Experience with LIMS systems, laboratory processes and computerized system validation (CSV) in regulated environments
• Knowledge of relevant regulatory requirements, e.g. GAMP 5, GMP, GLP or FDA 21 CFR Part 11
• Structured, analytical and solution-oriented way of working
• Strong communication skills as well as empathy and tact in dealing with diverse stakeholders
• Very good German language skills (minimum C1) and good English language skills
• Willingness to travel for customer assignments as required by projects
• Practical laboratory experience and knowledge of LIMS, ELN or LES systems are desirable