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 rst 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:

1 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.

2 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

3 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)

4 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.

5 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.

6 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

• Bachelors / masters degree in Instrumentation /Electronics / Automation Engineering.
• 1518+ years of relevant experience in Biopharmaceutical / Biosimilar manufacturing.