Senior Associate- Ds Engineering Job in Stelis Biopharma

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 onperiodical basis, aware of cGMP requirements, work towards the target set by the managementbased 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 equipments 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 equipments 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 equipments- 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 SOPs, 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