Manager - Instrumentation and 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. Job Purpose To lead and manage Instrumentation & Automation (I&A) activities for the DS Biosimilar facility, ensuring reliable, compliant, and efficient operation of automation systems supporting manufacturing, utilities, and compliance requirements. The role will drive automation strategy, system upgrades, regulatory compliance, audit readiness, and lifecycle management of automation platforms.

Responsibilities:

1️⃣ Automation System Leadership Lead and manage Siemens/Rockwell-based automation systems including: Siemens PLC (TIA Portal, SIMATIC Manager) PCS7 (including Batch processing as per ISA-88 standards) Oversee automation architecture for process and utility systems. Ensure high system availability and reliability for manufacturing operations.

2️⃣ Process System Expertise – Downstream & Upstream Provide technical oversight and support for automation related to: Upstream Systems Bioreactors Associated process control and monitoring systems Downstream Systems Centrifuges Chromatography systems Filtration systems Buffer preparation systems Utility & Support Systems Water systems (PW, WFI) BMS / EMS Clean utilities integration

3️⃣ Regulatory & Compliance Ensure compliance with: 21 CFR Part 11 GAMP5 Data integrity requirements Support internal and external audits (USFDA, MHRA, EU GMP, etc.) Review and approve validation documentation (URS, FS, DS, FAT, SAT, IQ, OQ)

4️⃣ Instrumentation & Controls Strong knowledge of: Field instrumentation Calibration practices Control valves, sensors, transmitters VFD systems Ensure robust preventive and predictive maintenance strategies. Support troubleshooting and root cause investigations.

5️⃣ Project & Upgrade Management Lead automation upgradation projects and system lifecycle management. Plan migration activities (legacy to upgraded platforms). Coordinate with cross-functional teams (Manufacturing, QA, CSV, Projects). Drive digitalization and continuous improvement initiatives.

6️⃣ Team & Stakeholder Management Lead and mentor automation engineers and technicians. Coordinate with OEMs and system integrators. Act as SME during regulatory audits. Ensure documentation and SOP adherence.

Technical Skills (Mandatory) Siemens PLC – TIA Portal & SIMATIC Manager PCS7 (Batch control knowledge as per ISA-88) Bioreactors Centrifuge systems Chromatography skids Filtration systems Water system automation BMS / EMS systems VFD configuration and troubleshooting 21 CFR Part 11 compliance Instrumentation & calibration knowledge

Qualifications

Bachelor’s / master’s degree in Instrumentation /Electronics / Automation Engineering. 15–18+ years of relevant experience in Biopharmaceutical / Biosimilar manufacturing.