About the role
Group Company: Stelis Biopharma Private Limited
Designation: Senior Associate (B54)
Office Location: Doddaballapura Bangalore
Years of experience: 5 to 7
Salary Range: INR to
Position description: Plant upgradation works planning, execution on periodical basis, aware of cGMP requirements, work towards the target set by the management based on business needs
Primary Responsibilities:
- Plant upgradation works planning, execution on periodical basis
- Plan & work towards the target set by the management based on business needs
- Updated & aware of cGMP requirements
- Plant operation & Maintenance of above equipment’s with respect to Electrical – Transformers, DG set, HT/ LT systems, Panels, UPS, Earthing system, HVAC, Utility, ETP, STP, FHS, BMS & EMS
- Plant operation & Maintenance of electrical related to – Black utility: Chiller, IBR boiler, Cooling towers, Air compressors, Clean utilities: Water pre- treatment system, Purified water, WFI, PSG i
- Process equipment’s – Formulation: Integrated filling lines of Cartridge, Vial & PFS with isolators, Autoclaves, Packing lines, CIP, SIP skids, Glass ware washers, Pass boxes, cold rooms & LAFs
- Process equipment’s- Microbial & Mammalian: Fermenters, Centrifuges, Homogenizer, HPLC columns, CIP & SIP systems of Drug product & Drug substance
- Preparation/Review of SOP, Preventive Maintenance schedule/planner, Documentation etc
- Knowledge of plant safety & cGMP requirements
- Coordination with user departments & work for Preventive/Breakdown maintenance
- Ensure smooth operation of plant & machinery to avoid breakdowns & production loss
- Plan for required spare parts inventory & AMC
- Manpower planning & reporting
- To conduct Periodical energy audits to improve the efficiency of the system & to bring down the operating cost
- Shift scheduling & operations
- Attend to plant breakdowns & plant activity
- Audit & Statutory Compliance
- Prepare/ Review/ Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ
- Computer skills including Auto CAD, Microsoft Projects
- Coordination with statutory authorities related to electrical
- Responsible for handling of controlled documents such as SOP’s, logbook and qualification protocol etc.
- Responsible to ensure preventive maintenance of the equipment is completed as per schedule and review the preventive maintenance schedule as per SOP
- Managing the inventory in effective and accurate manner
- Preparation of OPEX & CAPEX budget
- Bill review & certification related to engineering
- Coordination & working with CFT
Additional Responsibilities:
Reporting Team
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Educational qualifications preferred
- Category: Bachelor's Degree
- Field specialization: Electrical Engineering
- Degree: Bachelor of Engineering - BE
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