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Job

Senior CSV Engineer

  • Location

    Munich

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    James Brookes

  • Contact email:

    j.brookes@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • 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.