Specialist, Process Automation

Merck; Hyderabad; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Merck in Hyderabad seeks a Process Automation Specialist to own the DCS lifecycle, focusing on Siemens PCS7, PLC/SCADA, and CSV.

You will bridge process engineering, quality, and automated software workflows to keep manufacturing lines compliant, safe, and efficient across GMP suites. Leadership of a multidisciplinary team and coordination with vendors are key aspects.

Qualifications

• Requires deep hands‑on expertise with Siemens PCS7 batch architecture, PLC/SCADA systems, and CSV (GAMP 5).
• Bridges process engineering, quality control, and automated software workflows to maintain compliant operation.
• Leads automation engineers and vendors through lifecycle activities (URS to FAT/SAT).
• Ensures data integrity and regulatory compliance across OT systems.

Responsibilities

• Oversee daily operation and lifecycle of Siemens PCS7, PLCs, and SCADA across GMP suites.
• Manage upgrades, patches, and expansions to support manufacturing needs.
• Lead and mentor automation engineers and third‑party integrators; ensure 24/7 support.

Skills

DCS lifecycle ownership

Siemens PCS7

PLC/SCADA systems

GAMP 5 CSV

Regulatory compliance

CAPA investigations

Team leadership

Tools

Siemens PCS7

SCADA

MES Syncade

Werum PAS‑X

OSIsoft PI

Job description

Job Description

Spclst , Process Automation.

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.

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