Specialist, Process Automation

Overview

Specialist, Process Automation role in MSD's Hyderabad Technology Centre. The technical specialist owns the Distributed Control System (DCS) lifecycle for GMP biopharmaceutical manufacturing, covering Siemens PCS7 batch architecture, PLC/SCADA systems and GAMP 5 computer system validation.

What you'll do

• Oversee daily operation, continuous maintenance and system lifecycle of Siemens PCS7, PLCs and SCADA platforms across GMP manufacturing suites.
• Manage hardware and software upgrades, patches and system expansion to support changing manufacturing requirements.
• Maintain system backups, disaster recovery protocols and business continuity planning for all plant floor automation assets.
• Lead, mentor and develop a team of automation engineers, system administrators and third-party system integrators.
• Oversee resource scheduling to ensure uninterrupted 24/7 technical and plant floor troubleshooting support for active GMP manufacturing campaigns.
• Establish career development pathways, clear performance expectations and technical training programs for team members.
• Direct the automation engineering scope for capital expenditure (CapEx) projects, facility expansions and facility debottlenecking.
• Lead automation activities for New Product Introductions (NPI), collaborating with MS&T to configure process control recipes, phase classes and unit operations.
• Manage automation vendors and system integrators from initial User Requirement Specifications (URS) through Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Enforce data integrity policies across all OT systems aligned with 21 CFR Part 11, EudraLex Annex 11 and ALCOA+ principles.
• Author, review and approve validation lifecycle deliverables, including URS, Functional Specifications (FS), Design Specifications (DS), Risk Assessments and IQ/OQ/PQ protocols.
• Maintain computerized systems in an audit-ready state, acting as the primary Automation Subject Matter Expert (SME) during internal audits and regulatory inspections (FDA, EMA, etc.).
• Lead complex technical investigations for automation-related deviations and process upsets.
• Use systematic root-cause analysis methodologies to implement robust Corrective and Preventive Actions (CAPAs).
• Manage automation-related change control processes to ensure modifications are assessed, tested, validated and documented prior to deployment.
• Drive integration projects bridging plant floor control layers (Level 1/2) with Level 3 systems such as Manufacturing Execution Systems (Syncade, Werum PAS-X) and enterprise data historians (OSIsoft PI).
• Support automated batch record release initiatives by optimizing data flow between control systems and MES.

What you'll need

• Minimum requirement: B.Tech in Electrical/Instrument Engineering, Bioengineering, Computer Science or a related technical discipline.
• 5+ years of hands-on process automation experience in a cGMP biopharmaceutical manufacturing environment.
• Strong understanding of biological unit operations, including mammalian cell culture bioreactors, fermentation, Tangential Flow Filtration (TFF) skids, chromatography purification columns, Clean-In-Place (CIP/SIP) systems and Water-for-Injection (WFI) utility networks.
• Deep knowledge of configuring and troubleshooting automated process control loops, fieldbus protocols (Profibus, Foundation Fieldbus, DeviceNet, Modbus TCP) and industrial network switches.
• Primary skills: Biotechnology Process Automation.

Nice to have

• M.S. in Engineering or a related technical discipline.
• Automation Scripting; Automation Strategy.

Details

• Location: Hyderabad, Telangana, India (Hitec City Raidurg).
• Requires 24/7 technical and plant floor troubleshooting support coverage for active GMP manufacturing campaigns.
• Employee status: Regular. Travel requirements: Flexible.
• Job posting end date: 11/9/2026.