Job
Description
Strategic: Work towards continues improvements in automation & instrumentation to bring down the cost and technology advancement. Plant upgradation works planning, execution on Periodical basis. Able to visualize & plan the activity related to overall Project execution. Plan & execute the work towards the management goals. Able to handle DS and DP equipment’s Updated & aware of GAMP5, cGMP, statutory guidelines & standards requirements for automation and instrumentation. Plan for implementation of Automation layers Aware & update the latest software related to Automation & Instrumentation, DP, DS. Operational: Monitor the overall activity of Automation and Instrumentation activities. Plant level Automation and instrumentation breakdown diagnostics and maintenance for DP, DS, QC, EMS, BMS & Utilities. Support to Automation Layers implementation and validation. Calibration management including planning, execution, documentation and control for the plant level. Automation to support for upstream and downstream processing of MAbs/therapeutic proteins such as microbial, cell culture, chromatography, TFF, blast freezing, CIP/ SIP etc. Technical site support for CCTV, Access control, Door interlock. However main responsibility of maintaining & trouble shooting, planning & execution rests with facility management department. Coordinate with EHS team for trouble shooting of Fire alarm, PAS, VESDA & Gas suppression system. Technical site support for IT team for Data & Internet connectivity. However, main responsibility of maintaining & trouble shooting, planning & execution rests with IT department. Preparation/Review of SOP, Preventive Maintenance schedule/planner, Documentation etc. Coordination with user departments & plan for Preventive/Breakdown/ Calibration maintenance. Ensure smooth operation of plant & machinery to avoid breakdowns & production loss. And Coordination with user departments & plan for Preventive/Breakdown maintenance. Monitoring of outsource agency for plant operation. Review & coordinate for finalization of agreements. Preparation/Review/Training of SOP, Preventive Maintenance, Break down Maintenance, Schedule, Planning. Support Audit & follow Statutory Compliance. Review & approval of P & ID along with control & function layout drawings and electrical drawings. Prepare/ Review/ Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ. Monitoring of outcome agency for plant operation. Review & coordinate for finalization of agreements. Preparation and execution of QMS documents in the department. Goal setting to team members & annual review. Providing the same to the department head for review & approval. People: Shift scheduling, Manpower planning, reporting & Shift operations. Contract / Service provider Manpower/activities planning, reporting.
