Process Engineer

• Provide day‑to‑day troubleshooting for manufacturing equipment, automated systems, utilities, and process deviations to ensure uninterrupted operations.
• Lead and execute the Computer Validation Life Cycle (CVLC) for systems such as SCADA, PLCs, smart instruments, and networked control systems.
• Develop and execute FAT, IQ, OQ, and PQ protocols, including preparation of qualification reports and supporting documentation.
• Prepare and maintain SOPs , disaster recovery plans, backup strategies, and system configuration documentation.
• Conduct Quality Risk Assessments and Qualification Risk Assessments for equipment, utilities, and computerized systems.
• Support and manage engineering and validation activities for facility expansions , new equipment installations, and system upgrades.
• Perform commissioning, start‑up, and qualification of critical utilities including HVAC, compressed air, purified water systems, and facility infrastructure.
• Participate in investigations, CAPA development , and root cause analysis for process, equipment, and system failures.
• Review engineering drawings, P&IDs, material certifications, welding documentation, and construction packages for compliance and technical accuracy.
• Collaborate in HAZOP , hazard analyses, and safety assessments for new and existing systems.
• Develop and maintain Calibration Programs , HEPA filter certification processes, and software control systems.
• Prepare Validation Master Plans , analytical reports, and regulatory documentation to support audits and inspections.
• Work closely with cross‑functional teams including Manufacturing, Quality Assurance, Engineering, and Automation to ensure process robustness and compliance.

Requirements

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, Industrial, Biomedical, or related field).
• Extensive experience in process engineering , validation , metrology , and quality assurance within pharmaceutical or biotech manufacturing.
• Strong knowledge of 21 CFR Part 11 , GAMP , and validation of automated systems (SCADA, PLCs, HVAC, water systems, utilities).
• Demonstrated ability to perform technical troubleshooting on equipment and computerized systems.
• Experience in project management, facility start‑ups, equipment commissioning, and system upgrades.
• Proficiency in developing protocols, SOPs, risk assessments, and validation documentation.
• Experience with investigations, deviations, and CAPA management.
• Strong communication, teamwork, and leadership skills.