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 Workplace, Health, and Safety (EHS) guidelines during all maintenance activities, ensuring work permits (e.g., hot work, confined space) are utilized.

📌 Injectable Plant Maintenance - Executive /Sr. Executive || Ahmedabad
🏢 Adecco India
📍 Ahmedabad