Officer - Engg. & Maintenance (Pharmaceutical)

Job Title:

Job Purpose

To ensure smooth functioning, qualification, and maintenance of engineering systems and production equipment in compliance with cGMP and regulatory requirements.

Key Responsibilities

1. Prepare and maintain documents required for compliance with cGMP systems.
   
2. Plan, prepare, and execute equipment qualification activities.
   
3. Monitor and ensure timely execution of preventive maintenance activities.
   
4. Ensure all production equipment are properly qualified and maintained.
   
5. Review and approve all engineering-related documents.
   
6. Prepare engineering documents in line with regulatory and internal requirements.
   
7. Execute and document area qualification and compressed air qualification.
   
8. Prepare and maintain documentation for building maintenance services.
   
9. Plan and allocate daily jobs to technicians effectively.
   
10. Handle equipment breakdowns and ensure timely resolution.
    
11. Submit daily reports to the Engineering & Maintenance Assistant Manager.
    
12. Carry out additional responsibilities as assigned by the HOD.
    
13. Act as a designee in the absence of the Engineering & Maintenance Engineer.
    
14. Assume responsibilities of the Assistant Manager in his/her absence.
    
15. Provide data to QA for preparation of Annual Product Quality Review (APQR) related to engineering and maintenance.
    

Qualifications & Experience

• Education:

  B.E./B.Tech/Diploma in Mechanical / Electrical / Instrumentation Engineering (or equivalent).

• Experience:

  2–5 years of experience in Engineering & Maintenance within the pharmaceutical industry.

• Knowledge:

  cGMP, equipment qualification, preventive maintenance, HVAC, utilities, and regulatory requirements.

Skills Required

• Strong documentation and compliance knowledge (cGMP).
  
• Hands-on experience in equipment qualification and maintenance.
  
• Good problem-solving and troubleshooting skills.
  
• Team management and job allocation skills.
  
• Proficiency in preparing and reviewing engineering documents.
  
• Good communication and reporting abilities.
  

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