Process Engineer

Job Description

The Process Engineer at Piramal Critical Care (PCC) is responsible for leading hands-on troubleshooting, process optimization, and continuous improvement of GMP API manufacturing operations.

• Acts as SME for API manufacturing processes, utility systems, and unit operations including distillation, reactors, scrubbers, absorbers, and condensers.
• Accountable for process performance and drives improvements in yield, throughput, reliability, cost, and cycle time.
• Led troubleshooting and root cause investigations for deviations, batch failures, and process upsets using data-driven and structured problem-solving methods.
• Develops and maintains mass and energy balances to support optimization and debottlenecking efforts.
• Applies Statistical Techniques (SPC, DOE, etc) to monitor capability, reduce variation, and improve process stability.
• Tunes and optimizes process control systems, including PID loops, to improve operational performance.
• Leads Lean and Six Sigma initiatives focused on measurable process improvement.
• Supports capital projects through design, implementation, commissioning, and startup activities.
• Drafts and reviews URSs, SOPs, Change Controls, validation documents, technical reports, and investigations.
• Leads or supports PHA/HAZOPs, MOC, and incident investigations.
• PARTNERS Closely with Operations, Maintenance, and Automation to implement practical, field-based solutions.
• Maintains strong plant presence and responds to plant upsets with urgency and sound engineering judgment.
• Mentors junior engineers and provides technical leadership across manufacturing issues.
• DRIVES EXECUTION with a bias toward action and measurable results.
• Other duties as assigned.

Key Competencies

• Strong analytical and systems-thinking capability with ability to synthesize complex, multi-variable process data into clear technical conclusions and actionable decisions.
• Deep understanding of chemical engineering principles (thermodynamics, mass transfer, reaction engineering, fluid flow, heat transfer) applied to real manufacturing systems.
• Advanced problem-solving and critical thinking skills with demonstrated ability to independently resolve complex process issues in batch or continuous API manufacturing environments.
• Strong capability to interpret manufacturing data including historian data, batch records, process trends, and deviation histories to identify true drivers of performance.
• Working knowledge of Statistical Process Control (SPC) and statistical reasoning to assess process stability, variation, and capability.
• Strong understanding of pharmaceutical and chemical manufacturing systems including distillation, reactors, separations, heat transfer systems, and supporting utility networks.
• Working knowledge of Process Safety Management (PSM), including safe operation of high-hazard processes, operating envelopes, and risk-based controls.
• Experience working with or around highly hazardous chemical systems, including toxic, corrosive, and reactive materials such as chlorine and anhydrous HF, with strong safety awareness.
• Strong understanding of cGMP environments including validation, change control, deviation management, and regulatory compliance expectations.
• Ability to develop, interpret, and review technical documentation including URSs, SOPs, investigations, validation protocols, and engineering design packages.
• Strong leadership and influence capability with ability to align cross-functional teams and drive execution without direct authority.
• High bias toward action and decision-making, balancing technical rigor with urgency to ensure safe and reliable production performance.

Education/Experience

• Bachelor of Science in Chemical Engineering required.
• 8+ years of experience in chemical or pharmaceutical API manufacturing required; 10+ years preferred.
• Demonstrated expertise in troubleshooting and optimizing batch and/or continuous chemical processes in a cGMP manufacturing environment.
• Strong track record of driving measurable process improvements in yield, reliability, throughput, cost, or cycle time using data-driven methods.
• Lean Six Sigma Green Belt required; Black Belt strongly preferred with practical application in manufacturing environments.
• Experience with TrackWise, Aspen, SAP, and AutoCAD strongly preferred.