Switzerland Job Openings

ALTOGEN AG
Serialization Validation Engineer (M/F/X)
Lausanne
FULL TIME
November 15, 2024
With several years of experience, technical expertise, and project coordination, we support our partners throughout all areas of the product life cycles.
We surround ourselves with junior to expert consultants with strong development potential, whom we support in their professional goals.
Learn more about us on our webpage : www.altogen.ch
To strengthen our team in Switzerland, we are currently looking for a Serialization Validation Engineer (m/f/x).
ABOUT THE JOB :
As a Serialization Validation Engineer you will support manufacturing sites in validating serialization line systems, primarily at L2 (line-level) and L3 (site-level). This role is critical for ensuring compliance with industry standards while optimizing serialization processes.
- Validate and qualify serialization systems at L2 and L3 levels.
- Ensure processes comply with applicable regulations (GMP, Annex 11, etc.).
- Author and execute qualification protocols (IQ/OQ/PQ) for serialization systems.
- Collaborate with Manufacturing, IT, and Quality teams to ensure seamless integration of serialization systems.
- Identify, analyze, and resolve non-compliance issues.
- Provide technical support during internal and external audits.
- Degree in Engineering, Industrial IT, or a related field.
- At least 3 years of experience in validation or qualification in the pharmaceutical sector, with expertise in serialization.
- In-depth knowledge of L2/L3 levels and associated tools (e.g., line management systems, MES).
- Strong skills in technical documentation and validation.
- Solid understanding of regulations and standards applicable to the pharmaceutical industry.
- Fluent in English & French.
What we offer:
- A permanent contract and innovative projects
- An attractive remuneration policy
- Personalized management and continuous learning to develop your career
- Great team spirt and integration within the "Tribe"
Job Types: Full-time, Permanent
Schedule:
- Monday to Friday
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