CSV Engineer

We are seeking a versatile Computerized System Validation (CSV) Consultant to support one of our clients in validating computerized systems in a regulated environment. The consultant will be involved in critical projects ensuring compliance of computerized systems (MES, SCADA, LIMS, ELN, etc.). The contract duration would be set for an initial 6 months, with extension possibilities.

Responsibilities:
*Develop and execute validation plans for computerized systems in accordance with regulatory requirements.
*Write and review validation protocols (IQ, OQ, PQ) and validation reports.
*Ensure computerized systems comply with regulatory standards and Good Manufacturing Practices (GMP).
*Collaborate with project teams to ensure systems are properly validated and maintained.
*Participate in internal and external audits as a CSV subject matter expert.
*Manage validation procedures and regulatory requirements.
*Manage and validate computerized systems (MES, SCADA, LIMS, ELN, etc.) to ensure compliance and efficiency.

Qualifications:
*Degree in Computer Science, Engineering, Life Sciences, or a related field.
*5 years of experience in computerized system validation in a regulated environment.
*Experience in Commissioning, Qualification, and Validation (CQV).
*Knowledge of validation best practices (e.g., GAMP 5, 21 CFR Part 11).
*Ability to work independently and as part of a team
*Versatility and ability to manage multiple projects simultaneously.
*Fluent in German and English (spoken and written).