Qualification and Validation Specialist Pharmaceutical Production

Project overview

We are looking for an experienced Qualification and Validation Specialist to support our pharmaceutical production department. In this role, you will be responsible for planning, executing, and documenting comprehensive qualification and validation activities for production facilities, technical systems, equipment, and manufacturing processes.

Your tasks include the creation and review of qualification plans, specifications, risk analyses, test protocols, and final reports. You will carry out all phases of qualification – Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) – ensuring full GMP compliance. Furthermore, you will evaluate technical documentation and supplier documentation, manage deviations and changes, and resulting CAPA measures.

You will also be responsible for revising and further developing Standard Operating Procedures (SOPs) and internal qualification and validation guidelines.

We expect at least five years of experience in qualification and validation in pharmaceutical or comparable GMP-regulated environments. Sound practical knowledge in the qualification of pharmaceutical production facilities, technical systems, and equipment is required. You should have very good knowledge of GMP requirements and EU-GMP Annex 15, as well as practical experience with DQ, IQ, OQ, and PQ. Experience in managing deviations, changes, and CAPA measures is necessary.

Ideal candidates are characterized by their ability to translate technical requirements into understandable qualification and test documents. High initiative, a strong hands-on mentality, and willingness to undertake operational documentation work are essential.

Project details

• Start: 30.11.2026
• Duration: 1 Jahr +
• Location: DE
• Languages: German