Officer-Engg. & Maintenance (Pharmaceutical)

To ensure effective preventive and breakdown maintenance of process equipment used in manufacturing of tablets, capsules, and ointments. The role also includes responsibility for engineering documentation, compliance with GMP, and support for qualification, validation, and QMS activities.

Role & responsibilities

• Preventive Maintenance:
• Execute and monitor preventive maintenance schedules for process equipment (e.g., tablet compression machines, capsule filling machines, ointment manufacturing, etc.).
• Breakdown Maintenance:
• Attend to equipment breakdowns promptly and ensure minimum downtime.
• Root cause analysis and implementation of corrective and preventive actions (CAPA).
• Documentation & Logbook Maintenance:
• Maintain logbooks, maintenance records, and equipment history files.
• Ensure all maintenance and breakdown activities are recorded as per Good Documentation Practices (GDP).
• Calibration & Qualification:
• Coordinate and support calibration of process instruments and equipment.
• Assist in equipment qualification (IQ/OQ/PQ) and validation activities.
• GMP Compliance:
• Ensure engineering operations comply with cGMP requirements.
• Adhere to SOPs, safety standards, and plant hygiene norms.
• QMS Activities:
• Participate in QMS processes like Change Control, Deviations, and Risk Assessments (QRM).
• Support audit readiness and implement audit recommendations related to engineering.

Preferred candidate profile

• Qualification: Diploma / B.E / B.Tech
• Experience: 1 to 5 years (preferably in production or maintenance within pharmaceutical manufacturing of oral solid dosage forms and semi-solids).
• Skills:
• Hands-on experience with tablet, capsule, and ointment manufacturing equipment.
• Knowledge of preventive maintenance systems and documentation.
• Familiarity with GMP, GDP, and QMS.
• Basic understanding of calibration and validation processes.
• Good communication and coordination skills.