Job Description

Department Details

Role Summary

SM Automation

Key Responsibilities

The Automation/Digitization Program Leader is responsible to drive Pharma 4.0 maturity in Biocon\'s API and Formulations Manufacturing.

He/She is Accountable to implement DCS and other tools with various integration with L2, L3 and L4 Systems. He/she should strive to improve KPIs leveraging data insights and Productivity through next gen automation/digitization deployments.

Skills and Qualifications:

• B.Tech/M.Tech in Instrumentation/Electronics/ Computer Science
• 15+ Years experience in Pharmaceutical industry
• Hands-on experience in automation projects/DCS/SCADA/PLC / Digitization project management.
• Well versed with ISA S88, ISA S95, IEC 62443, ALCOA+, cGMP, 21 CFR Part 11, GAMP 5 and CSV Standards/Protocols/Guidelines and should be able to build and qualify systems as per the standards.
• Should have experience on Historian configuration and integration
• Should have L2/L3 integration experience as per ISA95 standard
• Should have hands on experience on batch engine as per ISA88 standard
• Should have experience in E-logbook and other Automation solutions implementation to improve the compliance
• Should have hands on experience on CSV qualifications as per GAMP 5 guideline
• Should handle large cross functional teams for implementation and qualification activities.
• Should handle vendor management activities.
• Should be able to present cost benefit analysis, proposals, and status reports to Sr. Management
• Excellent communication skills and stakeholder management. Ability to build consensus from shop floor to Sr. Management.

Educational Qualifications

Required Education Qualification: B.E
Required Experience: 14 - 16 years

Biocon