Job Title

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 PurposeTo 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 LeadershipLead 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 & UpstreamProvide technical oversight and support for automation related to:Upstream SystemsBioreactorsAssociated process control and monitoring systemsDownstream SystemsCentrifugesChromatography systemsFiltration systemsBuffer preparation systemsUtility & Support SystemsWater systems (PW, WFI)BMS / EMSClean utilities integration3️⃣ Regulatory & ComplianceEnsure compliance with:21 CFR Part 11GAMP5Data integrity requirementsSupport internal and external audits (USFDA, MHRA, EU GMP, etc.)Review and approve validation documentation (URS, FS, DS, FAT, SAT, IQ, OQ)4️⃣ Instrumentation & ControlsStrong knowledge of:Field instrumentationCalibration practicesControl valves, sensors, transmittersVFD systemsEnsure robust preventive and predictive maintenance strategies.Support troubleshooting and root cause investigations.5️⃣ Project & Upgrade ManagementLead 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 ManagementLead 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 ManagerPCS7 (Batch control knowledge as per ISA-88)BioreactorsCentrifuge systemsChromatography skidsFiltration systemsWater system automationBMS / EMS systemsVFD configuration and troubleshooting21 CFR Part 11 complianceInstrumentation & calibration knowledgeQualificationsBachelor’s / master’s degree in Instrumentation /Electronics / Automation Engineering.15–18+ years of relevant experience in Biopharmaceutical / Biosimilar manufacturing.