Project Design Engineer: Facilities and Utilities Expert

2 weeks ago

Bengaluru, Karnataka, India Syngene International Limited Full time

About Syngene International Limited:

Syngene International Limited, a leading contract research and manufacturing services company, is seeking a skilled Project Design Engineer to join its team. With over two decades of experience in the industry, Syngene supports R&D programs from lead generation to clinical supplies.

Job Purpose:

The successful candidate will be involved in the design and execution of projects related to lab facilities, utilities, and biologics facilities. Key responsibilities include developing project proposals, designing infrastructure projects, and ensuring compliance with safety requirements and GMP standards.

Key Responsibilities:

  1. Develop project proposals, including budget, milestones, and basic layouts.
  2. Design review and approval for all infrastructure projects.
  3. Design and review of safety requirements and processes.
  4. Develop project strategies, including time schedules and cost estimates.
  5. Establish and record project communication protocols.
  6. Develop detailed project, financial, and contracting strategies.
  7. Ensure compliance with designs and specifications.
  8. Project governance, including regular updates to management.
  9. Project internal review mechanism with CFT, consultants, and contractors.
  10. Perform overall quality control of the work.
  11. Compliance with SOPs, cGMP, and EHSS standards.
  12. Coordination with CFT for utility and facility DQ, FAT, SAT, IQ, OQ, and PQ.
  13. Design knowledge of HVAC, mechanical utilities, and infrastructure coordination drawings.
  14. Conceptualization and preparation of layouts for biologics facilities, injectable facilities, and laboratories.
  15. Design understanding of brownfield project expansion, including detailing and gap analysis.
  16. Perform overall quality control of the work and report regularly on project status.
  17. Collaborate with project staff to create strategic action plans and cost estimates.
  18. Collaborate with design groups to adapt plans in response to problems.
  19. Creation of concept notes, URS/drawings, etc., for new projects.
  20. Follow-up with project-related vendors and monitor work related to mechanical, HVAC, clean rooms, electrical, IT, paneling, utilities, etc.
  21. Understanding, reviewing changes to drawings related to mechanical works – HVAC, clean utilities, plant utilities, layouts, etc.
  22. Execution of facility and equipment commissioning and qualification of Syngene Compliance.
  23. Collaboration with engineering cross-functional teams.
  24. Ensuring training compliance for staff and contractors/vendors.
  25. Ensuring facility and equipment commissioning and qualification of Syngene Compliance in collaboration with the Quality department.

Educational Qualification:

BE/BTech in Mechanical/Electrical Engineering.

Technical/Functional Skills:

  • Good knowledge of the Pharma/Biotech industry environment.
  • Knowledge in GMP sterile facility quality systems (DI, deviation, and change management).
  • Knowledge in guidelines like ASME-BPE, EU GMP, ISO 14644, and ALCOA principles.
  • Bioprocess/sterile operations will be a plus.
  • AutoCAD and Microsoft Project skills.
  • Possess knowledge and exposure to EHSS practices.

Experience:

Overall 14-18 years of industry experience, with 10-12 years of relevant manufacturing facility construction and management experience.

  • Good knowledge in Mechanical/HVAC.
  • Good knowledge in clean room and biosafety levels.
  • Bio process/sterile industrial experience is preferable.

Behavioral Skills:

  • Good communication skills in English.
  • Collaborative team player.
  • Growth mindset, positive approach.
  • Quick learner.

Equal Opportunity Employer:

Syngene International Limited is an equal opportunity employer. We do not discriminate against any employee or job candidate based on age, color, physical ability, ethnic origin, nationality, religion, gender, family status, marital status, pre-natal status, gender reassignment, or sexual orientation.

We make appropriate accommodations for eligible workers or job candidates with disabilities wherever possible.

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