CSV and IT Compliance Engineer/Manager
vor 6 Stunden
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CSV and IT Compliance Engineer/Manager, Yverdon-les-BainsClient:Location:Job Category:Other
Job Reference:8d92ecf7598f
Job Views:6
Posted:21.01.2025
Expiry Date:07.03.2025
Job Description:4-6 months contractor – FRENCH Speaking necessaryOur customer is an innovative biopharmaceutical Big Pharma company. For an on-site assignment for the brand new commercial manufacturing site, we are looking for 2 experts in CSV for the Pharma Industry.
As part of their continuous growth, our client is implementing new IT systems at their local manufacturing and packaging units. To support these initiatives, we are seeking an experienced CSV and IT Compliance Engineer/Manager.
You have:
- Bachelor’s degree in Science, Engineering, or a related discipline.
- 7-10 years of experience in the pharmaceutical or biotechnology industry, including expertise in Quality Management Systems and GxP systems such as MES and SAP.
- Proficiency in Computer System Validation (CSV), Data Integrity requirements, and regulatory frameworks (21-CFR Part 11, EudraLex, MHRA).
- Experience with Six Sigma, Lean, or Business Process Change techniques is a plus.
- Strong analytical and structured working style with exceptional attention to detail.
- Excellent communication and collaboration skills to work in multidisciplinary, international teams.
- Fully operational in both English and French.
- Swiss residency or a valid Swiss work permit is mandatory (cross-border candidates welcome).
- Ensure compliance with pharmaceutical industry standards and regulations, including EU-GMP Annex 11 and 21-CFR part 11.
- Lead Computer System Validation (CSV) activities for site IT systems and infrastructure.
- Act as the local representative for global IT projects with quality implications, such as Digital Modernization initiatives.
- Oversee the qualification of site IT infrastructure in collaboration with global teams.
- Define quality expectations and support the IT department and third parties in implementing GMP-compliant systems.
- Conduct risk-based prioritization of IT activities in support of Quality Assurance.
- Translate compliance requirements into test conditions and acceptance criteria for application functionality (IQ, PQ, FAT).
- Ensure adherence to design and governance standards while contributing to effective communication with stakeholders.
You will:
- Be part of an innovative, dynamic team at a globally recognized biopharmaceutical leader.
- Work on impactful projects that directly support patient outcomes.
- Enjoy a collaborative work environment with opportunities for professional growth.
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