Senior Executive - Engineering (Plant Maintenance - Injectables)

Intas; Bavla; On-site; INR 600,000 - 900,000; Full time

Job summary

Intas Pharmaceuticals SEZ Plant in Bavla, Gujarat, India seeks an Equipment Maintenance professional to oversee aseptic processing equipment upkeep, calibration, and repair across vial washers, autoclaves, filling and sealing lines.

The role emphasizes cGMP compliance, documentation, and audit readiness, with collaboration across engineering, validation, and EHS to minimise downtime and ensure product quality.

Qualifications

• Educational qualification: BE/B.Tech/M.E./M.Tech in engineering.
• Experience in maintaining pharmaceutical processing equipment.
• Strong knowledge of cGMP and cleanroom practices.
• Excellent documentation and audit readiness.

Responsibilities

• Oversee maintenance and troubleshooting of core injectable machinery (vial wash, sterilization tunnels, filling/sealing, lyophilizers, autoclaves).
• Manage maintenance for bung washing, capping, and visual inspection lines.
• Identify root causes of mechanical and electrical breakdowns to minimise downtime in cleanrooms.
• Plan and execute shutdown maintenance activities efficiently.

Skills

Sterile equipment

Troubleshooting

cGMP adherence

Documentation

Education

BE/B.Tech / ME / M.Tech

Tools

Vial Washers

Sterilization Tunnels

Filling & Sealing Machines

Lyophilizers

Autoclaves

Capping machines

Visual inspection lines

Job description

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