Computer System Validation Engineer

4 weeks ago

Baddi, India PQE Group Full time

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.


Due to our constant growth, we are looking for a SeniorCSV Expert to support our projects in Baddi, Himachal Pradesh (India). The resource will collaborate with our Global team and our India team.



You'll Be Responsible For:

  • Analysing software application user requirements and performing risk assessments following the CSA approach
  • Developing test cases and scripts according to the risk category of each user requirement
  • Executing test cases and gathering relevant evidence for validation
  • Documenting any deviations or issues identified during testing
  • Preparing CSV lifecycle documentation, as needed
  • Conducting all activities within the Polarion CSV tool in compliance with VMP/Procedures
  • Ensuring compliance with industry regulations, including 21 CFR Part 11, Annex 11, Data Integrity, and data security standards
  • Collaborating with global and India-based teams, ensuring efficient communication and seamless project execution.
  • Execute designed test cases and collect evidence for test execution.
  • Document any deviations/failure during test execution.
  • Prepare CSV lifecycle documents (if required).
  • All above activities will be handled within electronic systems (Polarion CSV tool) as per defined VMP/Procedures from the organisation.


About You:

  • A minimum of 5 years of experience in Computer System Validation (CSV), with a focus on GAMP Category 4 and 5 projects.
  • Demonstrated expertise in validating enterprise applications and performing risk-based assessments.
  • Strong knowledge of regulatory standards such as 21 CFR Part 11, Annex 11, and Data Integrity guidelines
  • Excellent communication skills with the ability to work independently and within teams
  • Flexibility to work onsite or remotely, depending on project requirements
  • Familiarity with Polarion CSV tool or similar platforms is highly desirable
  • Availability to travel
  • Good knowledge of English



First project you will assigned to:

Location: India, Baddi, Himachal Pradesh

Duration: 3-6 months

Availability: Full on site


Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.


Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.

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