Senior Executive - Engineering (Plant Maintenance - Injectables)

Role & responsibilities: -

Equipment Maintenance & Operations

• Sterile Processing Equipment: Oversee the maintenance and troubleshooting of core injectable machinery including Vial Washers, Sterilization Tunnels, Vial/Ampoule Filling and Sealing machines, Lyophilizers (Freeze Dryers), and Auto-claves.
• Component Processing: Manage maintenance for bung washing machines, capping machines, and visual inspection lines.
• Breakdown Resolution: Identify root causes of mechanical and electrical breakdowns swiftly to minimize production downtime in cleanrooms (Class A/B/C/D).
• Planned Downtime: Plan and execute shutdown maintenance activities efficiently.

Compliance & Documentation

• cGMP Adherence: Ensure all maintenance activities comply with standard operating procedures (SOPs) and current Good Manufacturing Practices (cGMP).
• Documentation Management: Maintain accurate, real-time logs of equipment maintenance, breakdown reports, history cards, and validation protocols.
• QMS Participation: Initiate and handle Quality Management System (QMS) documents, including Deviations, Change Controls, and Corrective and Preventive Actions (CAPA) related to engineering failures.
• Audit Readiness: Prepare documentation and present engineering systems during regulatory audits (e.g., USFDA, MHRA, WHO, EU-GMP).

Calibration & Validation

• Schedules: Execute the calibration schedule for process instruments, temperature/pressure sensors, and gauges.
• Validation Support: Assist the validation team in Re-qualification, IQ/OQ/PQ (Installation, Operational, and Performance Qualification) of process equipment.

Safety & Cleanroom Protocol

• Cleanroom Discipline: Strictly follow aseptic gowning protocols and maintain sterile area disciplines.
• EHS Compliance: Enforce Environment, Health, and Safety (EHS) guidelines during all maintenance activities, ensuring work permits (e.g., hot work, confined space) are utilized.

Preferred candidate profile: -

• Required Experience: - 4 to 12 Years
• Required Educational Qualification: - B.E. / B.Tech. / M.E. / M. Tech.

Regards,

Human Resources Team,

Intas Pharmaceuticals SEZ Plant