Validation Engineer (CQV) – Qualification DQ/IQ/OQ/PQ

You own qualification and validation activities on GMP equipment, from the validation strategy through execution to documentation. Your goal: validation that holds up in an audit.

• Writing and executing qualification plans (DQ/IQ/OQ/PQ).
• Risk-based validation strategies to Annex 15.
• Deviation management and assessment in a GMP context.
• Producing audit-proof documentation and supporting audits.

• Degree in engineering, natural sciences or pharmacy.
• Experience in qualification and validation in a GMP environment.
• Familiar with Annex 15, GAMP 5 and ALCOA+.
• Very good German; English an advantage.

• Demanding projects on real GMP equipment in the life sciences.
• Short paths, flat hierarchies and real responsibility from day one.
• Work close to operations rather than from a distance, in a collegial engineering team.
• Fair, performance-based employment terms and continuing education.