DM / Manager – Cell & Gene Therapy – Engineering

• Desired Profile Diploma / BE in electrical and electronics, with QMS related certifications with 10+ Years of experience

Job Description, Key Skills and Competencies:

• Expertise in Facility and Engineering related QMS documentation and activities such as writing lab instrument/equipment/ utilities SOPs, preparation of qualification documents ( DQ,IQ,OQ & PQ), deviation handling, Change control, risk assessment , CAPA, qualifications and commissioning documents etc
• Working with different internal and external stakeholders for smooth implementation and functioning of the engineering maintenance activities, which includes but not limited to preparation of documents across different functional teams and external vendors, reviewing, implementing the required process, follow-ups etc
• Expertise in Facility modification commissioning and Qualifications documentation
• Having thorough knowledge in Operation and Maintenance of LAB Equipments like Co2 Incubators, Deep Freezer, Autoclave, Bio safety Cabinet, LAF, Stability Chamber, Cooling Incubators, Lab Centrifuges Water bath, Hot air Oven, Incubator Shaker, Water Purification System, Bioreactor, Cold Rooms ,Liquid Nitrogen System Etc
• Having thorough knowledge in for Operation and Maintenance of analytical instruments like, Flow Cytometer, Spectrophotometer, Multimode Microplate Reader, Chemical Image System, Gel Image System, Osmometer, PH & Conductivity Meter, Weighing Balance ,Western Blot Instruments , Etc
• Sound knowledge in Utility Equipments , Operation and maintenance of HVAC Equipments like Air handling units, Chiller, Cooling tower and BMS Monitoring system Preparation & Review of schedule/ Planner for the periodic Maintenance activities of Lab Instruments, Utility & Facility Equipments Co- ordinating for corrective and Preventive action on the observation during internal/External audits
• Responsible for Coordination with external Vendor and OEM Service Provider for periodic PM and Calibration activities and breakdown activities
• Responsible for operation and Maintenance of Utility Equipments like transformer, DG, Air compressor, Nitrogen generator, LT Panels Etc
• Coordinate along with External vendor and OEM service provider for breakdown or any facility Modification activity Responsible for Execution, verification and support the New Projects or Facility Modification Activity
• Having good knowledge in safety practices and procedures, sustainability programs, hygiene maintenance etc