Drug Product Engineering Director

2 weeks ago

Johor Bahru, Johor, Malaysia Biocon Biologics Full time

Job Title: Director of Product Engineering

Key Responsibilities
  1. To carry out planned preventive maintenance on all plant and equipment aiming to achieve maximum plant availability with a target of zero unplanned downtime.
  2. To raise communication memo for Preventive Maintenance.
  3. To maintain availability of spare part of all equipment at all time and ensure no downtime due to non-availability of spare part.
  4. To respond, carry out and record equipment maintenance activity effectively and efficiently.
  5. Observation and rectification of equipment/machines condition and detection of unusual conditions in a proactive manner.
  6. Ensure all equipment is operated and maintained as per manufacturer's recommendation.
  7. Familiarization with the manufacturing process and related equipment.
  8. To communicate with external vendor for site services/repair.
  9. Daily reporting of activities and updating any issues at work to the superior.
  10. Support commissioning/validation activities that include FAT/SAT/DQ/IQ/OQ and PQ.
  11. To attend, record and conduct all trainings required as per training matrix/schedule.
  12. Generate various document procedure/protocol/report as and when required.
  13. Fill log sheets/checklist/history card/planner as described in the SOPs.
  14. Follow the established procedures and policies of the company.
  15. Participate in project activity on process optimisation, facility upgrade, or objective.
  16. To propose objectives and targets on work area and comply to set timeline.
  17. Participate in cost and energy management program.
  18. To conduct/participate and ensure smooth running of any audits (Internal and external) related to QMS and EHS management system.
  19. To provide feedback and ensure all the audit findings are closed within the stipulated time.
  20. On routine basis to provide improvement proposal on equipment, process, or quality system.
Educational Qualifications

Required Education Qualification: MA/M.Com/M.Sc

Biocon Biologics is an Equal Opportunity, EEO / Affirmative Action Employer committed to excellence through diversity. All qualified applicants will receive consideration for employment without regard to, and no employee shall be discriminated against because of their race, color, religion, age, sex (including pregnancy), national origin, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable federal, state or local law.

Seniority level

Director

Employment type

Full-time

Job function

Biotechnology Research and Pharmaceutical Manufacturing

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