Job Summary
Ensure operational excellence by managing instrumentation and automation systems, driving compliance, and supporting continuous improvement across Biocon's biopharma manufacturing facilities.
Key Responsibilities
- Coordinate all activities related to document control, including technical documents, drawings, and commercial correspondence.
- Input and maintain document data in registers, ensuring accuracy and uptodate information.
- Generate, review, and maintain procedures, protocols, and reports related to QMS and EHS management systems.
- Ensure latest approved documents/protocols for instrumentation and automation are in place and accessible.
- Review, register, and safeguard documents under secure custody with easy traceability.
- Gain familiarity with manufacturing processes and related equipment to support engineering operations.
- Communicate with external vendors for site services, repairs, and technical support.
- Provide daily reporting of activities and escalate issues to superiors.
- Support commissioning and validation activities (FAT, SAT, DQ, IQ, OQ, PQ).
- Attend, record, and conduct trainings as per training matrix/schedule.
- Participate in projects related to process optimization, facility upgrades, and cost/energy management programs.
- Propose objectives and targets for work areas and ensure compliance with timelines.
- Ensure smooth execution of internal and external audits related to QMS and EHS, and close findings within stipulated timelines.
- Provide routine improvement proposals on equipment, processes, and quality systems.
Requirements
- Bachelor's degree in Engineering (Instrumentation, Automation, Electrical, or related discipline).
- 35 years of experience in instrumentation and automation within pharmaceutical, biopharma, or regulated manufacturing industries.
- Strong knowledge of QMS, EHS, and compliance frameworks.
- Handson experience with commissioning, validation, and troubleshooting of automation systems.
- Familiarity with manufacturing processes, equipment, and vendor management.
- Excellent documentation skills with attention to detail and compliance with ALCOA principles.
- Strong analytical, problemsolving, and communication skills.
- Ability to work collaboratively in crossfunctional teams and manage multiple priorities.
