Automation & Instrumentation Lead
JOB Description.
Regular operations/Maintenance
1. Responsible for smooth plant operation of Instrumentation & automation activities of Production, Utility,
2. Annual planning of Maintenance budget, AMC, CAPEX, Liasioning / Networking with Statutory bodies, Calibration.
3. Coordinate for implementing periodic maintenance, Calibration activities and Emergency break down of various instruments and PLC, DCS automation systems.
4. Driving road map for digital transformation and Best Manufacturing practices (Industry 4.0).\
5. Implement advanced automation technologies and IoT Solutions to connect Process Equipment & Engineering Utilities to accomplish Quality & regulatory advantages.
6. Update Standard Operating procedures, checklist and review annual calibration, AMC schedules.
7. Implementation of best practices, CAPA, Audit observations and cGMP guidelines for continuous development and upgrading of plant operations.
8. Co-ordinating with QA and Engineering CFTS for investigations/CAPA and related change controls.
9. Review and implementation of Horizontal and vertical deployments CAPAs
10. Ensure proper planning of Team training and compliance as needed.
11. Co- coordinating with Vendor and procurement for in timely order, delivery for goods and services.
12. Responsible for adherence to safety, cGMP, WHO norms for various projects, 21 CFR part 11, GAMP5 etc.
13. Perform Process assessment and Implement automation towards minimizing manual errors to support Data integrity and increase process accuracy towards minimizing write offs.
14. Facilitate development and capacity building of the team by interdisciplinary training.
Projects
1. Strong engineering contribution to process development / Equipment design review in sterile process in collaboration with Cross-functional team and SMEs.
2. Finalization of Automation philosophy, Process & Utility automation, Material-handling automation, Field instrumentation, Computer system validation for Sterile Facility. Co-ordinate with vendor/User/CFTs for developing DQ/FS in line with URS. Supporting User and CFTs for preparing Equipment URS in line with 21 CFR compliance and IT policies
3. Ensure On time support for Calibration, and validations form internal and external resources
4. Commissioning, Qualification and validations for EMS/BMS/UMS.
5. Attend and lead the FAT of equipment as needed.
6. Planning activities Follow the schedule and update on time to project co - coordinator and lead.
7. Complete owner ship of Instrumentation related functions – From URS to Validations.
8. Ensuring timely design, procure, commissioning, documentation & execution of projects vis-a-vis budgets
Must to have
1. Good knowledge in cGMP in pharma/Biotech industry.
2. Strong knowledge of Automation (PLS/SCADA and system architecture) in terms of current and futuristic needs.
3. CSVMP
4. Good hold on EMS/UMS/BMS
5. Able to convent user automation needs in to FS.
Good to have
1. Knowledge on PLC programming.
2. Energy conservation with help of Automation.
