Process Engineer

4 weeks ago

Hyderabad, Telangana, India Aurigene Pharmaceutical Services Limited Full time

Job Title: Process Engineer - Peptides

Location: Hyderabad, Telangana, India

Job Summary: We are seeking a highly motivated and experienced Process Engineer with a strong background in peptide process development, scale-up, and technology transfer. This critical role will support our business, ensuring the efficient and robust development and manufacturing of peptide molecules from lab to commercial scale. The successful candidate will leverage their expertise in downstream techniques, process optimization, and problem-solving to drive project success and contribute significantly to our clients' drug development pipelines.

Key Responsibilities:

  • Lead and execute process engineering activities for peptide molecules, including process development, scale-up, and technology transfer (R&D to pilot/commercial manufacturing).
  • Apply in-depth knowledge of downstream techniques: preparative HPLC (ion exchange, reverse phase, normal phase), lyophilization, tangential flow filtration, nano filtration, and micron filtration.
  • Conduct process understanding studies, generate data for unit operations (reaction, distillation, extraction, crystallization, filtration, drying), and assess process scalability.
  • Evaluate and select plant facilities, propose modifications, and ensure timely completion of plant modifications for commercial scale, including CAPEX evaluation.
  • Identify hardware requirements for commercial scale based on lab, kilo lab, and pilot plant data.
  • Re-engineer difficult or hazardous unit operations using safety studies data (DSC/TGA/Reaction Calorimeter) and conduct HAZOP and risk analysis.
  • Perform particle characterization studies (PVM, FBRM) to assess process parameter impact on morphology, particle size, and distribution; support powder processing for desired PSD.
  • Manage batch planning, scheduling, and execution at commercial scale, including troubleshooting for timely technology transfer and delivery.
  • Monitor pre-validation and validation batches; implement learnings/recommendations.
  • Drive time cycle reduction and debottlenecking initiatives for peptide molecules (SPPS, purification, lyophilization).
  • Coordinate effectively with cross-functional teams (R&D, Analytical, QA, RA, CMCQA, Production, Safety) for smooth operations and project delivery.
  • Prepare and review technical documents: Part-C (EHS Package), PED (Process Engineering Document), technology transfer checklists, and exothermic reaction assessment reports.
  • Contribute to capacity enhancement and cost improvement projects by optimizing processes and reducing raw material consumption.
  • Provide technical services, process troubleshooting, and root cause investigation with robust CAPA implementation.
  • Evaluate Request for Proposals (RFPs) and contribute to facility upgradation based on production requirements.

Required Skills & Experience:

  • Bachelor's or Master's degree in Chemical Engineering or a related field.
  • Minimum of 3 - 8 years of hands-on operational experience in process engineering within the pharmaceutical industry.
  • Proven expertise in peptide process development, scale-up, and technology transfer, demonstrated by successful projects involving complex peptide molecules

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