Job TitleProcess Engineer
Job Description
Process Engineer responsible for leading hands-on troubleshooting, process optimization, and continuous improvement of GMP API manufacturing operations
Essential Duties and Responsibilities- 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.
- Leads 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 (knowledge, skills, and abilities every person must possess to be successful)
- 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.
Physical Demands:Physical Effort (Occurrence frequency for each activity)ActivityN/AOccasionallyFrequentlyContinuouslySitting/Standing/Walking:
ContinuouslyBalancing/ Kneeling/Crouching/Stooping:
OccasionallyCrawling/Climbing:
OccasionallyReaching/Working Overhead:
FrequentlyKeyboard Use/Repetitive Hand Motion:
ContinuouslyPushing/Pulling (up to 50 pounds):
OccasionallyLifting/Carrying (up to 50 pounds):
OccasionallyReporting to this position: N/A Individual Contributor
General Oversight and Direction:Receives moderate to limited supervision working from objectives set by Manager. Employee organizes and carries out most assignments in accordance with standard practices, instructions or previous training. Employee handles some situations independently.
The above statements reflect the general duties and responsibilities considered necessary to perform the essential functions of the job. This document should not be considered a fully detailed description of all the work requirements of the position. Piramal Critical Care may change the specific job duties with or without prior notice based on the needs of the organization.
