Assistant General Manager Process Engineering

Description:

The position is responsible for designing, developing, and implementing robust pharmaceutical production processes that enable efficient, economical, and compliant mass manufacturing. The role focuses on process design, optimization, scale-up, and validation across the product lifecycle. The incumbent designs equipment layouts, production sequences, and operating procedures to maximize productivity and quality. The role conducts process testing, variable control, and troubleshooting across all manufacturing stages. It provides technical guidance to product and equipment design teams to ensure optimal utilization of manufacturing technologies. The position ensures regulatory compliance, process reliability, and audit readiness, while supporting technology transfer, continuous improvement, and sustainable operations.

Essential Functions:

• Design and optimize manufacturing processes for efficient and compliant production
• Define process flow, equipment layout, and operational sequencing
• Lead process scale-up, technology transfer, and commercialization readiness
• Conduct process trials, testing, and variable control studies
• Troubleshoot process deviations, inefficiencies, and production issues
• Ensure process validation (IQ/OQ/PQ) and lifecycle compliance
• Develop and execute process validation master plans
• Support equipment design, installation, and operational qualification
• Drive continuous improvement, lean manufacturing, and cost optimization
• Ensure quality, audit readiness, and regulatory compliance
• Collaborate with Quality, Engineering, and Manufacturing teams
• Maintain technical documentation, change control, and process records
• Manage talent capability, retention, training, and knowledge-sharing frameworks
• Responsible for overall site engineering leadership for regulated Oncology Injectable Formulation plant, covering plant maintenance, utilities, projects, engineering compliance, new line installation and audit readiness.
• Should have independently led engineering function with 40+ team members across maintenance, utilities, electrical, instrumentation, automation, calibration and projects.
• Must have hands-on exposure in installation, commissioning, qualification and operational handover of new injectable production lines, including filling line, lyophilizer, vial / PFS line, isolator, compounding and packaging equipment.
• Should own 24x7 plant uptime, aseptic area support, equipment reliability, breakdown control, preventive / predictive maintenance and shutdown planning.
• Strong command over clean utilities, black utilities, HVAC, BMS / EMS, WFI, PSG, PW, compressed air, chilled water and cleanroom compliance is required.
• Must be capable of directly facing USFDA / MHRA / EU inspections and driving engineering CAPA, deviation, change control, DQ / IQ / OQ / PQ, validation support and GMP documentation.
• Expected to partner with Production, QA, QC, EHS, Projects and Site Leadership for new line readiness, batch continuity, capacity enhancement, compliance closure and audit preparedness.Must have proven experience in OEE improvement, MTBF / MTTR improvement, energy saving, capex planning, vendor governance, engineering budget control and statutory compliance.

Additional Responsibilities: