Process Design Engineer

1 week ago

pune, India BioTalent Search Private Limited Full time

Job Title: Process Design Engineer (API)

Location: Pune, with extensive travel across India and abroad

Experience: Minimum 7 to 10 years in Process Engineering


Job Description:

We are seeking a highly skilled and experienced Process Design Engineer specializing in Active Pharmaceutical Ingredients (API) and formulation process engineering functions. The ideal candidate will have a robust background in process engineering and be adept at managing and executing various engineering tasks.

Key Responsibilities:

  • Process Engineering: Prepare block drawings, process flow diagrams (PFDs), piping and instrumentation diagrams (PIDs), equipment specifications, and utility calculations.
  • Process Design: Develop process time cycles, equipment sizing, containment strategies, and design black & clean utilities. Conceptualize layouts and prepare Basis of Design (BOD) documents.
  • Vendor Evaluation: Perform technical evaluations of vendor offers for process equipment, clean utility, and plant utility systems.
  • Project Supervision: Oversee commissioning and supervision of project installations.
  • Protocol Preparation: Develop Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for manufacturing vessels, water systems, autoclaves, etc.
  • Commissioning and Qualification: Lead the commissioning and qualification of manufacturing vessels, water systems, autoclaves, and vial filling machines.
  • Equipment Management: Design equipment layouts and specifications for reactors, centrifuges, dryers, columns, pumps, filters, and utility package systems.


Candidate Profile:

  • Education: Bachelor’s degree in Engineering (BE/B Tech) in Chemical Engineering.
  • Knowledge: Must be well-versed with Schedule M, ISPE guidelines, and current Good Manufacturing Practices (cGMP).
  • Communication Skills: Excellent command of English, both written and verbal.
  • Interpersonal Skills: Strong interpersonal skills with the ability to handle and work within teams effectively.
  • Teamwork: Demonstrated ability to lead teams and be an effective team player.

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