Qualification and Csv Expert

vor 1 Woche

Kaiseraugst, Schweiz ITech Consult AG Vollzeit

**Project**: For our client, a large pharmaceutical company based in Basel, we are looking for a Qualification and CSV Expert.

**Background**:
The Qualification Unit of Engineering and SHE at the Kaiseraugst site is seeking reinforcement for the qualification of embedded systems. Embedded systems are production systems with embedded process automation systems, e.g., SCADA/HMI. To ensure a successful production site in Kaiseraugst, we drive progress through scientific and technical expertise and proactive service. We achieve this through continuous process improvement, an agile workforce, and a great deal of passion. Our interface role will provide you with numerous contacts across the entire manufacturing area.

**Tasks & Responsibilities**:

- Implementation and documentation of qualification processes for our embedded systems / process automation systems in accordance with cGMP.
- Development, implementation and execution of test strategies, test plans and test cases to verify system performance and conformity.
- Technical participation in the creation of specifications (e.g. URS)
- Collaboration with the IT, process engineering / automation, quality assurance and production departments to ensure smooth integration and qualification of the systems.
- Creation and maintenance of qualification documentation (DQ, IQ, OQ, PQ) and supporting design documents such as data flow diagrams and audit trail review assessments
- Processing of qualification impact assessments as part of change or deviation process management a proactive and self-reflective way of working in expert teams.

**Must Haves**:

- Degree in a natural sciences/engineering program or relevant professional experience.
- At least 3 years of professional experience and in-depth experience in the qualification process and CSV
- Practical professional experience with qualifications and validation of various types of systems.
- Several years of experience in the GMP field with a deep understanding of quality systems and the lean implementation of GMP requirements.
- Solid experience in strategic and conceptual work, with strong project management and self-management skills.
- Good documentation practices in a GMP environment.
- Very good written and spoken English and German skills.

**Nice to haves**:

- Practical experience with common process control systems (e.g. Siemens Simatic)
- Sound knowledge of regulatory frameworks (ICP, GMP Guidelines including Annex 11, Annex 22)
- Experience in fully electronic qualification (Val genesis)

**Personal skills**:

- Highly independent and structured working style with a commitment to continuous improvement of oneself and processes
- High degree of initiative, flexibility, and quick comprehension
- You are characterized by a solution-oriented approach and the ability to find practical solutions even in complex situations.
- Good communication skills for efficient teamwork
- Team spirit, enthusiasm for cross-functional collaboration, and the ability to actively contribute to a positive working environment.

**Reference No.: 924474**
**Role: Qualification and CSV Expert (M/F/d)**
**Industry: Pharma**
**Place of work: Kaiseraugst**
**Working hours: 100%**
**Start: Asap (latest start: 01.02.2026)**
**Duration: 2 years**
**Application deadline: 13/10/2025**

**Job Type**: 100%

Work Location: On the road

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