PHARMACEUTICAL PROCESS ENGINEER

Description

Job Summary: Design, optimize, control, and improve pharmaceutical manufacturing processes, ensuring efficiency, quality, and regulatory compliance—from conceptual engineering to operational support. Key Highlights: 1. Key role in pharmaceutical process design and optimization 2. End-to-end involvement from conceptual engineering through validation 3. Focus on efficiency, quality, and regulatory compliance **1\. Job Objective** Design, optimize, control, and improve manufacturing processes to ensure: * Operational efficiency, * Product quality, * Regulatory compliance, * Industrial safety, * Cost reduction, * Operational continuity, * Productivity and scalability. Participation spans conceptual engineering, validation, commissioning, continuous improvement, and operational support. **2\. Potential Work Areas** **Primary: Pharmaceutical Industry** * Solid oral dosage forms * Liquids * Sterile products (injectables) * Semisolids * Biotechnology * APIs * Purified water (PW)/Water for Injection (WFI)/Pure Steam (PS) * CIP/SIP **3\. Core Responsibilities** **Process Design** * Development of PFDs and P\&IDs * Material and energy balances * Equipment specification * Technology selection * Definition of production capacities * Specification of critical utilities **Process Optimization** * Bottleneck analysis * Reduction of downtime * Performance improvement * Energy efficiency **Validation and Compliance** Especially in pharma: * IQ/OQ/PQ * FAT/SAT * URS/DQ * Risk assessment * Compliance with NOM\-059 * FEUM * FDA * EU GMP * ISPE * GMP’s * GAMP5 **Operational Support** * Deviation resolution * CAPA * Change control * Failure investigation * Production support * Troubleshooting **Document Management** * SOPs * Technical specifications * Protocols * Reports * Operating manuals * Risk matrices * FMEA analysis **Automation and Control** * PLC * SCADA * HMI * Instrumentation * Process integration * Alarms and trends **4\. Responsibilities** * Ensure stable and reproducible operation * Ensure regulatory compliance * Maintain production capacity * Reduce operational costs * Process design and quality assurance * Participate in audits **5\. Required Technical Knowledge** **Process Engineering** * General knowledge of pharmaceutical processes * Thermodynamics and heat transfer * Fluid mechanics * Material balances * Sanitary design * Hydraulics * Pneumatics **Technical Documentation** * PFD * P\&ID * Layout * Datasheets * URS * FAT/SAT/IQ/OQ/PQ protocols **Software** * AutoCAD * SolidWorks * Revit * Visio * AutoCAD Plant 3D * DeltaV * Siemens TIA Portal **Quality and Regulatory Standards** **Pharma** * NOM\-059 * FEUM * FDA 21 CFR Part 210/211 * EU GMP Annex 1 * ISPE Baseline * ASME BPE **Industrial** * NOM\-STPS * ISO 9001 * ISO 14644 * OSHA * NFPA **6\. Soft Skills** * Technical leadership * Critical analysis * Problem solving * Working under pressure * Effective communication * Project management * Analytical thinking * Decision making **7\. Academic Background** * Chemical Engineering * Mechanical Engineering * Industrial Engineering * Pharmaceutical Engineering **8\. Typical Experience:** 3–6 years * Process design * Partial project leadership * Validations * Optimization * Water system calculations **Responsibilities:** * Design and optimize GMP pharmaceutical processes * Coordinate FAT/SAT/IQ/OQ/PQ * Manage deviations and CAPA * Implement productivity improvements * Ensure compliance with NOM\-059 and FDA Salary: $17,000\.00 \- $21,000\.00 per month Benefits: * Company parking * Option for indefinite-term contract * Discounted cafeteria service Work Location: On-site employment