Process Engineer - Peptide

Job Title: Process Engineer - Peptides

Location:

Job Summary:

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