Required skills
- CSV
- Qualification
- Validation
- Pharmaceutical Production
- Technical Systems
- Equipment
- GMP
- EU GMP Annex 15
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Languages: German
Job description
Seeking a Senior CSV Specialist with at least 5 years of experience in qualification and validation within the pharmaceutical or a comparable GMP-regulated environment. The role involves planning, executing, and documenting validation activities for production facilities, technical systems, and equipment.
Responsibilities
Project No.:
1085301
Project Title:
1085301 Senior CSV Specialist Pharma
Job Type:
freelance
- Planning, execution, and documentation of qualification and validation activities for:
- pharmaceutical production facilities
- technical systems
- equipment
- 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 specifications
- Ensuring complete, traceable, and GMP-compliant documentation
Requirements
Additional Information:
SOLCOM is one of the leading technology service providers in the areas of software development, IT, and engineering. For over 20 years, we have been working as partners with globally operating top companies in all industries and are deployed worldwide wherever innovation is decisive.
- 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 facilities, technical systems, and equipment
- 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
- 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
Project details
Zell (Canton of Lucerne)
2026-11-30
1 year +
- Start: 2026-11-30
- Duration: 12 Monate
- Remote: onsite
- Location: Zell (Kanton Luzern), Deutschland, DE
- Languages: German
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