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Senior CSV Specialist
vor 2 Monaten
We are seeking a highly skilled and experienced CSV specialist to join our team at gloor&lang AG. As a contractor, you will be working on a 12-month project with our international biopharmaceutical client.
The ideal candidate will have a strong background in Computer System Validation (CSV) in the pharmaceutical environment and experience with GAMP 3 and 4. You will be responsible for implementing and validating off-the-shelf and configurable systems, as well as collaborating on GAMP 5 worldwide/interconnected systems.
The successful candidate will have excellent communication skills, both written and verbal, and be fluent in French and English. You will be working closely with our client to ensure that all systems meet the required GMP standards.
Key Responsibilities:
- Explain and obtain IT requirements and GMP regulations from vendors and customize systems as needed to comply with GMP.
- Guarantee data integrity of systems in their environment and process.
- Design, elicit, analyze, document, and validate detailed user, functional, and non-functional requirements to ensure business needs are met.
- Adjust deliverables, their quality, and complexity to meet timelines and fit validation approach.
- Assist in translating compliance requirements into test conditions and expected results for application functionality and acceptance testing.
- Drive development and execution of change management and training throughout the organization during system implementation and ongoing use.
Requirements:
- Pharmaceutical, biotechnology, or life science industry experience is a must.
- 5-10 years' experience as an IT engineer running projects from requirements to delivery of final product and documentation.
- Familiarity with change management tools and regulated document authoring.
- COTS and web-based requirements, architecture, Agile/SCRUM methodology.
- Proven experience in installation and qualification of Aveva-PI suites and Building Automation systems (Desigo, RMS Rotronic) is a strong plus.
- Experience in Computer System Validation.
- Awareness of 21-CFR Part 11, Eudralex, MHRA.
- Fully operational in French and English.
We are looking for a highly skilled and experienced CSV specialist who can work autonomously, analyze problems, and achieve deliverables. If you have a strong influence on colleagues and can drive positive outcomes, we encourage you to apply.
About gloor&lang AG:
We are a leading consulting firm specializing in life science talent solutions. Our team of experts has a deep understanding of the pharmaceutical industry and can provide tailored solutions to meet your needs.
