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.