Manager - Instrumentation Automation

Biocon Biologics
is a fully integrated 'pure play' biosimilars organization globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led-global biopharmaceuticals company and India's first publicly listed biotech enterprise. Biocon Biologics has one of the largest biosimilars portfolios, a wide global footprint, state-of-the-art manufacturing facilities, world-class R&D ecosystem, and high quality & compliance standards, enabling it to fulfil unmet needs of patients across the globe.

Qualification: -

B.E/B. Tech/M. Tech in Electronics and Instrumentation/Instrumentation and Control/Electronics and Communication with 18 to 23 Years experience in BioPharma/Fermentation Plant /Biologics API Manufacturing DS plant.

Key Responsibilities: -

• Lead the instrumentation and automation team of Engineers to manage all process equipment in upstream Fermentation, downstream WFI/PUW/RO water plants and PSG for ensuring operational efficiency and quality compliance.
• Provide expert-level troubleshooting support for attending breakdowns / issues with automated systems and field instruments connected to various process equipment to upkeep the plant as per operational needs.
• Oversee Instruments Calibration/PM programs and corrective maintenance activities for all instrumentation and automated systems to ensure that all performed as per defined frequency.
• Should already having experience in facing all major Regulatory and customer Audits. USFDA, EMEA, PMDA, MHRA etc., and all regulatory audits from various countries.
• Responsible for managing the OPEX and Capex budgets (plant modification & Control system upgrades) and maintain the same within approved numbers.
• Driving the team to close all QMS elements within the Target dates (CCF, Deviation and CAPAs).
• Excellent interpersonal and communication skills to lead a team and collaborate with stakeholders. Should work with Cross-Functional Teams, including Engineering, Manufacturing, Quality Assurance and Commercial Teams to integrate automated processes and achieve project goals.
• Should manage spares procurement and Inventory control.
• Should be familiar with operation and maintenance of large-scale OEM production equipment for supporting the team during critical break down to fix the problems within minimum downtime- Fermenters, NDVs, CIP Skids, CIEX column, Centrifuge, RPHPLC column, Freeze Driers, Autoclave, GMP Washer connected with PLC/DCS and SCADA systems.
• Should have hands on experience and troubleshooting knowledge in ABB DCS/SCADA systems with Foundation Field bus for all Field Instruments and Profinet communication for all pneumatic panels & VFDs.
• Should be having strong technical knowledge and hand on experience in troubleshooting & software modifications for Allen Bradely PLCs widely from Micro logix to L7/L8 series controllers, HMI and SCADA systems FTSE software in Server/Thin clients.
• Should be familiar with Siemens Win CC SCADA software, SQL Server and Rockwell Logix software RS Logix 5000 , RS Logix 500.
• Strong understanding of pharmaceutical regulations, especially cGMP, and their application to automation and instrumentation.
• Driving the team for Operational Excellence, Kaizen, LSS for improving the overall efficiency.