Senior Validation Engineer

1 month ago

pune, 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 Senior Validation Engineer (Thermal & Environmental) to support our projects in Pune .


You’ll be responsible for:


  • Performing and reviewing the validation of autoclaves, CPS systems, de-pyrogenation tunnels, ovens, fermenters, and other thermal equipment
  • Validating cold rooms, industrial freezers, incubators, and controlled temperature areas/chambers
  • Leading and supporting validation activities, including execution, calibration, and documentation review
  • Diagnosing and resolving issues that occur during validation, such as sensor setup, data logger placement, load configuration, and technical equipment setup
  • Identifying and addressing discrepancies or non-conformances with technical precision to ensure compliance with industry standards
  • Assisting in the preparation for and participation in various regulatory audits, ensuring validation deliverables meet compliance requirements
  • Managing vendor staff deployed at the client site to ensure their technical competency and that they meet the required qualifications



About You:


  • Previous experience in thermal and environmental validation , with at least 5 years of experience in the pharmaceutical industry
  • A Bachelor’s degree in Engineering (preferably BE or equivalent). Advanced degrees are a plus
  • Proven track record of working in highly regulated environments such as pharma or biotech, with in-depth knowledge of validation protocols and regulatory guidelines
  • Strong understanding of validation execution, calibration, sensor setup, data logging, and troubleshooting validation issues
  • Ability to resolve technical discrepancies, ensure non-conformances are addressed with precision, and adapt to changing project requirements
  • You have a sharp eye for reviewing validation documentation and ensuring accuracy across all deliverables
  • Experienced in supporting regulatory audits and maintaining compliance in validation processes



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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