PQE Group | Critical Utilities Expert

2 days ago

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 43 subsidiaries and more than 1700 employees in Europe, Asia and the Americas.


Following a new opportunity, we are currently looking for an Critical Utilities Expert with experience in the Pharma sector/consulting firm to support our projects in India.


You'll be responsible for:

  • Developing user needs and strategies for water systems in compliance with regulations.
  • Leading the engineering activities for WFI, purified water storage and distribution, clean steam systems, and water pre treatment systems.
  • Preparing design packages such as feasibility studies, Concept Design (CD), Front-End Engineering Design (FEED), and Detailed Design (DD).
  • Performing design calculations, equipment sizing, utility calculations, and loop design for water systems.
  • Preparing and reviewing DQ, IQ, OQ, URS, and technical specifications for water systems.
  • Ensuring compliance with USP and ISPE guidelines for water system design and validation.
  • Designing clean room HVAC systems for pharmaceutical facilities, adhering to USFDA, EU CGMP, WHO, and UKMHRA standards.
  • Preparing project design packages for HVAC disciplines, including feasibility studies and detailed designs.
  • Monitoring and qualifying HVAC systems to ensure compliance with regulatory and EHS standards.
  • Supporting audits and reviews to maintain statutory compliance and implement energy conservation strategies.
  • Designing generation and distribution systems for compressed air, nitrogen, and other process gases.
  • Preparing design packages for compressed air and nitrogen disciplines, including P&IDs and equipment specifications.
  • Inspecting, monitoring, and qualifying utility systems in compliance with regulatory guidelines.



About You:


  • 10+ years in the pharmaceutical industry or consulting (MUST HAVE)
  • Proven expertise in critical utilities such as water systems, HVAC, compressed air, and nitrogen.
  • Exposure to international projects, particularly in Europe and the U.S.
  • Deep knowledge of water systems (WFI, purified water, clean steam) design and operation.
  • Expertise in cleanroom HVAC systems design, monitoring, and validation.
  • Proficiency in designing compressed air, nitrogen, and utility generation systems.
  • Strong understanding of regulatory standards (USFDA, EU CGMP, WHO, UKMHRA) and ISPE guidelines.
  • Experience in DQ, IQ, OQ preparation and execution for critical utilities.
  • Skilled in P&ID development, utility calculations, and equipment sizing for utility systems.


Preferred Qualifications:

  • Experience with tender preparation and Bill of Quantity (BoQ) for utility systems.
  • Knowledge of CIP/SIP design and clean utility philosophies.



Location

  • 90% Remote, with occasional travel for on-site support as required.



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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