Senior CSV Specialist Pharma

Project overview

Planning, execution, and documentation of qualification and validation activities for:

pharmaceutical production equipment

technical systems

devices

manufacturing processes

Creation and review of:

Qualification plans

Specifications

Risk analyses

Test protocols

Final reports

Planning and execution of:

Design Qualification (DQ)

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Evaluation of technical documentation and supplier documentation

Processing of deviations, changes, and resulting CAPA measures

Revision and further development of SOPs as well as internal qualification and validation guidelines

Ensuring complete, traceable, and GMP-compliant documentation

Requirements

Min. 5 years of experience in qualification and validation in the pharmaceutical or comparable GMP-regulated environment

Sound practical experience in the qualification of pharmaceutical production equipment, technical systems, and devices

Very good knowledge of GMP requirements and EU-GMP Annex 15

Practical experience with DQ, IQ, OQ, and PQ and associated documentation

Experience with processing:

Deviations

Changes or modifications

CAPA measures

Ability to translate technical requirements into comprehensible qualification and test documents

High level of initiative and strong hands-on mentality

Willingness to take on a high proportion of operational documentation work

Additional Information:

Project No.: 1085301

Job Type: Location: Start: 30.11.2026 Duration: 1 year +

Project details

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