LIMS Consultant, Validation Expert

Darum lohnt es sich

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