SME Freeze Dryer

Title:

Job Grade:

Location:

• Should have knowledge about the

  process cycle of a Freeze Dryer.

• Should have capability for

  installation and commissioning

  of Freeze Dryer.
• Should have knowledge about selection of material for Freeze Dryer based on product.
• Should have knowledge about

  instrumentation and operation of components

  installed on Freeze Dryer.
• Should have knowledge about critical components like

  compressor, vacuum pumps, LRP, CIP circulation pump, silicon oil circulation pump, valves, hydraulic station, Alus, pizza door.

• Should have hands-on experience in

  operation and maintenance

  of Freeze Dryers of various makes.
• Should have knowledge about control systems of the Freeze Dryer involving PLC, SCADA, IPC.
• Should have knowledge about refrigeration cycle.
• Responsible for

  maintenance management

  (breakdown and preventive maintenance) for all Freeze Dryers available at site.
• Should have knowledge about complete process from raw material sampling/dispensing to finished goods (sampling/dispensing/manufacturing/filtration/filling/FD loading/FD unloading/capping/packing).
• Should have knowledge about product characteristics based on which cycle shall be designed.
• Would be the Single Point of Contact (SPOC) for Lyophilizer OEMs for technical discussions in order to set good engineering practices and monitor preventive maintenance centrally.
• Should be able to liaise and communicate with cross-functional teams (Quality and Production).
• Should have knowledge about formulation equipment such as filling line equipment (washing/depyrogenation tunnel/filling/freeze dryer/capping/leak testing/inspection/X-ray).
• Should have knowledge about Quality Management System (QMS) like change control, CAPA, unplanned deviation, and investigation.
• Should have knowledge about maintenance management (breakdown and preventive maintenance) of all equipment.
• Should be able to prepare SOPs for operation and maintenance of equipment.
• Would be responsible to face and respond to auditors/agencies technically on Freeze Dryers.
• Should be able to handle third-party vendors during day-to-day activities and installation of equipment.
• Should have knowledge about execution, documentation, and coordination with third-party vendors for CSV and PCS (Process Control System) qualification and validation.
• Should have knowledge about SAP system for PM, calibration, and breakdown maintenance.
• Responsibility would be to manage critical spares of Freeze Dryer like TC gasket, O-ring, door gasket, diaphragm, pumps, valves, sensors, driver, PLC module, etc.
• As an SME, should be able to train operators and engineers working on Freeze Dryer.
• Should be able to handle project work related to digitization, automation, and upgradation of systems and equipment.
• Should ensure safety standards are maintained at site and ensure safety procedures are available and followed strictly in accordance with relevant regulations.
• Should be able to do technical coordination with the procurement team and follow up with vendors for material and project/service work.
• Should ensure GMP documents are maintained as per SOP.
• Should ensure timely compliance with internal and external audit observation points.

Travel Estimate

Up to 50% | They will be travelling 12-15 days a Month, and should be ok to travel to all sites globally

Job Requirements

Educational Qualification

Mechanical/Electrical/Mechatronics Engineering degree or equivalent.

Experience

10-15+ years experience

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

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