Role Purpose

Lead process engineering for the API manufacturing site to deliver safe, compliant, robust, scalable, and cost-effective manufacturing processes. Provide technical leadership across facility and process design, operational improvement, capacity expansion, yield enhancement, and technology transfer. Translate business needs into technically sound projects and sustain measurable improvements throughout the product and asset life cycle.

Key Responsibilities

1. Facility and Process Design

- Lead conceptual, basic, and detailed process design for greenfield, brownfield, debottlenecking, and modernization projects in multipurpose API facilities.
- Guide team to develop design basis, process flow diagrams, piping and instrumentation diagrams, equipment layouts, and control philosophies.
- Lead equipment sizing and selection for reaction, filtration, centrifugation, drying, milling, distillation, solvent recovery, and other API unit operations.
- Ensure designs incorporate cGMP, data integrity, maintainability, operability, cross-contamination control, occupational exposure controls, and EHS-by-design principles.
- Lead process safety reviews, including HAZOP, risk assessment, and inherently safer design.

1. Operational Improvement and Troubleshooting

- Develop and lead a structured process improvement pipeline aligned with site safety, quality, service, cost, and sustainability priorities.
- Use process data, mass and energy balances, root-cause analysis, and Lean methods to eliminate losses and improve process capability.
- Resolve recurrent process and equipment problems by partnering with Production, Quality, Engineering, Maintenance, EHS, and R&D.;
- Standardize successful solutions through procedures, batch records, operating ranges, and training.
- Establish and monitor OEE frameworks with reliable data collection, dashboards, and daily performance reviews to improve equipment uptime and reduce unplanned stoppages.

1. Capacity Expansion and Debottlenecking

- Own product and equipment capacity models, cycle-time studies, and constraint identification.




- Develop expansion scenarios covering campaign strategy, batch-size optimization, equipment modifications, and capital requirements.
- Prepare technical and financial business cases with throughput benefit, cost savings, and return on investment analysis.
- Lead implementation and post-start-up benefit verification.

1. Yield, Cycle-Time, and Cost Improvement

- Establish product-wise baselines for yield, solvent and raw-material consumption, cycle time, utility use, and conversion cost.
- Lead yield improvement through reaction optimization, crystallization studies, mother-liquor recovery, and drying optimization.
- Optimize solvent recovery, cleaning practices, and batch execution to reduce cost without compromising quality or regulatory commitments.

1. Automation and Process Digitalization

- Develop the automation roadmap for critical API unit operations, prioritizing safety, process consistency, containment, and data integrity.
- Translate process requirements into user requirement specifications, functional requirements, control narratives, and alarm strategies.
- Partner with Engineering, IT/OT, Quality, and Production to implement PLC, DCS, SCADA, MES, and data-analytics solutions.
- Ensure automation solutions comply with GxP, computer-system validation, access control, and cybersecurity requirements.
- Lead commissioning, qualification, operator training, and benefit realization for automated processes.

1. Technology Transfer and Scale-Up

- Collaborate with Manufacturing Science & Technology to support engineering workstreams for new-product introduction, scale-up, and site-to-site transfer.
- Review development and site packages for process descriptions, critical process parameters, critical quality attributes,



and equipment needs.
- Perform facility-fit and equipment-gap assessments, scale-up calculations, and risk-based transfer planning.
- Define transfer deliverables, resource plans, timelines, and readiness criteria.
- Ensure effective knowledge transfer, traceable technical decisions, and robust handover to routine manufacturing.

1. Technical Leadership and Governance

- Lead, coach, and develop process engineers; set technical standards, priorities, and review routines.
- Act as the site subject-matter expert for API process engineering and plant design.
- Lead activities in project, quality, safety, operational, and management reviews. Qualifications
- Bachelors degree in Chemical Engineering is required; a masters degree in Chemical Engineering, Process Engineering, Pharmaceutical Engineering, or a related field is preferred.
- Typically 10-15 years of progressive process engineering experience in pharmaceutical API, fine chemicals, or a closely related regulated batch-processing industry.
- At least 3-5 years of experience in improvement projects with OEE implementation.
- Demonstrated delivery in several of the following: API facility design, scale-up, technology transfer, brownfield expansion, debottlenecking, yield improvement, automation, commissioning, qualification, and process validation.
- Robust working knowledge of cGMP, quality systems, process safety, data integrity, and regulated change control.
- Proficiency with process documentation (PFDs, P&IDs;, URS, control narratives), automation platforms (PLC, DCS, SCADA, MES), and continuous-improvement methods (Lean, Six Sigma, root-cause analysis, FMEA).
- Experience with project management, capital justification, commissioning, qualification, and process simulation or data-visualization tools.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

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