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CSV Engineer

Job Seekers Denmark Science Life Science

Job Summary

  • Denmark
  • Contract
  • BBBH823835
  • Jul 28, 2022
  • Competitive
Job Description

An opening for a Computer Systems Validation Engineer has come to market with a large multinational pharmaceutical company based in Denmark.

Main responsibilities:

  • Preparation of Decommissioning/Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ, OQ/PQ), Data Migration, SOPs and Change control.
  • Manage, co-ordinate, develop and execute the validation deliverables for new Information System (IS) and current projects.
  • Support and co-ordinate the qualification, decommissioning and validation processes.
  • Responsible for ensuring that computerised systems are in full compliance with regulatory requirements, company policies and procedures.
  • Provide compliance leadership, direction, and execution in Computer System Validation for new and existing projects
  • Support the resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.) Participate in required project teams.
  • Responsible for ensuring that the Technical Development Manager is consulted on all validation deliverables.

Minimum qualifications:

  • Degree in Science/Engineering or related area
  • 3 years' experience in a similar role
  • Knowledge of cleaning validation a distinct advantage
  • Experience in oral solid dose a distinct advantage
  • Must have experience in decommissioning of equipment & writing of protocols

If this role is of interest to you please get in touch on 021 2300 300 or by email at nmurphy@morganmckinley.ie

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

Nikita Murphy
Nikita Murphy
  • Consultant | Engineering Recruitment
  • +353 21 2300 300
  • nmurphy@morganmckinley.com