The Opportunity
•Based in Hyderabad, join a global healthcare biopharma company and be part of a 130-year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
•Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products.
•Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats.
Our Technology Centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of our company's IT operating model, Tech Centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy.
A focused group of leaders in each Tech Center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centers.
Role Overview
This position requires a technical specialist who owns the Distributed Control System (DCS) lifecycle and understands the complexities of biopharmaceutical manufacturing. The ideal candidate possesses deep hands-on expertise with Siemens PCS7 batch architecture, PLC/SCADA systems, and GAMP 5 Computer System Validation (CSV).
Unlike traditional IT or generic industrial automation roles, the Process Automation Specialist must seamlessly bridge the gap between process engineering, quality control, and automated software workflows, ensuring continuous compliant operation of clinical and commercial manufacturing lines.
What will you do in this role:
1. Automation System Ownership
•Oversee the 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.
2. Team Leadership & Development
•Lead, mentor, and develop a high-performing 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.
3. CapEx & Technology Transfer
•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 (Manufacturing Science & Technology) 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).
4. Regulatory Compliance & Computer System Validation (CSV)
•Enforce data integrity policies across all OT (Operational Technology) 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 agency inspections (FDA, EMA, etc.).
5. Deviation & CAPA Resolution
•Lead complex technical investigations for automation-related deviations and process upsets.
•Use systematic root-cause analysis methodologies to identify underlying issues and implement robust Corrective and Preventive Actions (CAPAs) to prevent recurrence.
•Manage automation-related change control processes to ensure modifications are assessed, tested, validated, and documented prior to deployment.
6. Digital Plant Initiatives
•Drive integration projects bridging plant floor control layers (Level 1/2) with Level 3 systems, such as Manufacturing Execution Systems (MES) (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 should have:
Educational Background
•Minimum Requirement: B Tech in Electrical/Instrument Engineering, Bioengineering, Computer Science, or a related technical discipline.
•Preferred: M.S. in Engineering or a related technical discipline.
Professional Experience
•Experience: 5+ years of hands-on process automation experience in a cGMP biopharmaceutical manufacturing environment.
Technical & Bioprocess Acumen
•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 (must-have)
•Biotechnology
•Process Automation
Secondary Skills
•GxP Compliance
•Process Engineering
Required Skills
Automation, Automation Control System (ACS), Automation Engineering, Automation Solutions, Automation Systems, Change Controls, Data Engineering, Data Visualization, Design Applications, Design Modifications, Equipment Calibrations, Equipment Reliability Improvement, Equipment Repairs, Equipment Testing, Manufacturing Execution Systems (MES), OSIsoft PI Historian, Pharmaceutical Process Development, Root Cause Identification, Root Cause Investigations, SCADA System Design, Site Acceptance Testing, Software Configurations, Software Development, Software Development Life Cycle (SDLC), and 5 more.
Preferred Skills
Automation Scripting, Automation Strategy
Who we are
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
