PQE Group | Process/Design Engineer

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 a Process/Design Engineer to support our projects in India.


You'll be responsible for:


  • Evaluating and selecting appropriate equipment for Oral Solid Dosage (OSD) and sterile manufacturing processes.
  • Performing capacity calculations, equipment selection, and sizing to meet production goals.
  • Developing plant equipment layout concepts, process flow diagrams, and P&IDs.
  • Designing facility layouts that optimize workflow while adhering to regulatory requirements.
  • Preparing project design packages such as feasibility studies, Concept Design (CD), Front-End Engineering Design (FEED), and Detailed Design (DD).
  • Reviewing and preparing qualification documents like DQ, IQ, OQ, PQ, FAT/SAT protocols, and reports.
  • Ensuring compliance with CGMP regulations (USFDA, EU CGMP, WHO, UKMHRA) and EHS requirements.
  • Preparing for internal audits and regulatory inspections by maintaining complete documentation.
  • Designing containment areas for potent compounds and biologics.
  • Developing waste management and contamination control strategies.
  • Troubleshooting process equipment in sterile and solid facilities.
  • Providing process input to architects and cross-functional teams.
  • Managing vendors and supporting manufacturing operations.
  • Conducting feasibility studies and risk analyses.



About You:


  • 10+ years in the pharmaceutical industry or consulting (MUST HAVE)
  • Proven process engineering experience in design consultancy or GMP manufacturing.
  • Exposure to international projects in Europe and the U.S.
  • Expertise in OSD, sterile, and biologics formulations.
  • Strong knowledge of process calculations, safety, and regulatory compliance.
  • Experience preparing project documentation and plant layouts.


Technical Skills:

  • Proficient in Microsoft Office, AutoCAD, Revit, and Microsoft Project.
  • Solid understanding of quality systems, risk assessment, and hazardous area classification.
  • Familiarity with process safety and CGMP requirements.


Preferred Qualifications:

  • Experience with sterile processing and contamination control.
  • Willingness to travel for on-site support (1-2 trips per quarter, 1-3 weeks per trip).



Location:

  • 90% Remote, with periodic travel for on-site support.



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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