Senior CSV Engineer
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Location
Munich
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Sector:
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Job type:
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Contact:
James Brookes
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Contact email:
j.brookes@hamlynwilliams.com
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Salary high:
0
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Salary low:
0
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Published:
9 months ago
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Expiry date:
2020-05-31
Senior CSV Engineer – Munich, Germany
We are working alongside a leading engineering consultancy and they are looking to speak with CSV engineers who have more than 5 years experience to work with a number of clients across the DACH region. This role is a permanent position and comes with an excellent salary as well as a generous package. This role will be based out of the Munich office.
Skillset:
- -Resolution of fundamental CSV compliance issues
- -Align with e‐Compliance on project management and life cycle documentation deliverables for GxP relevant projects
- -Ensure all project related risks are well managed and deliverables are validated (for GxP)/tested (for non‐GxP) in accordance to SOP and the associated CSV requirements
- -Ensure project team complies with the methodology and SOP and uses the correct tools
- -Ensure completeness and consistency of project life cycle documentation
- -Ensure all project related issues and deviations are recorded, approved and dispensed accordingly (including ensuring proper deviation report preparation and approval)
- -Prepare project and life‐cycle reports and review/approve all other documents to ensure compliance with SOP
- -Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in document repository (Document Navigator) and approved in accordance to the prescribed SOP
Requirements:
- 5-8 years of Computer System Validation or any validation experience required
- -Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report)
- -German - full professional proficiency (min. C1), English language proficiency
- -Excellent communication skills
- -Ability to work as a team player in a consulting environment
- -Able to manage direct relation with stakeholders and project team members
- -Proactive approach
- -Results driven oriented
If you are interested in a long term opportunity like this then please send your CV to n.wren@hamlynwilliams.com and click apply below.