Job Description :

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 Positive 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.

Preferred candidate profile: -
Required Experience: - 7 to 14 Years
Required Educational Qualification: - B.E. / B.Tech. / M.E. / M. Tech.

📌 Injectable Plant Maintenance Senior Executive For Ahmedabad Location (India)
🏢 Adecco India
📍 India