CSV Engineer
vor 4 Wochen
We are seeking a skilled CSV Engineer to join our team at agap2 - HIQ Consulting. As a CSV Engineer, you will be responsible for ensuring the validated state of computerized systems on manufacturing sites, including laboratory equipment.
Key Responsibilities- Create CSV documents, including risk analyses, traceability matrixes, and validation protocols.
- Organize the review of CSV documents by QA teams.
- Execute CSV tests and support CSV timelines.
- Write CSV reports.
- Collaborate with CSV and CQV lead Engineers.
- Interact with Process Engineers, Automation Team, PM, and QA.
- Ensure GAMP5 compliance and follow ASTM guidelines.
- Hold an engineering diploma in Biotechnology, Bioprocess, or Chemical Engineering, or similar.
- Minimum of 3+ years in Commissioning, Qualification, and Validation, including CSV, with strong experience in managing complex pharmaceutical projects.
- Expertise in automation and vertical integration, as well as data management under validated computer systems.
- Knowledge of planning CQV activities, leading large senior reports.
- Proven management experience in an EMA/FDA regulated environment with good knowledge of current ICH, PIC/S, EU, and US regulatory requirements and their implementation.
- Fluency in English and German.
Join a group with strong development potential that aims to improve your employability on challenging and varied projects.
- Join a structure that has been established in Switzerland for a long time with a client portfolio that includes leaders in the sector.
- Have a sustainable job with stability and access to a real collaboration.
- Benefit from training with accredited and certified centers.
- Have a local management team to support you in the achievement of your missions and in the development of your career.
- Be part of a dynamic, committed team with real human values that we live by every day.
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