Senior Specialist DDIT OPS, Automation Engineer

Role Summary

The Senior Specialist DDIT OPS, Automation Engineer will oversee and lead the IT/OT team to ensure reliable 24/7 operations of the manufacturing plant, providing technical support, system maintenance, and issue resolution to minimize downtime and optimize plant performance.

Responsibilities

• IT/OT Team Leadership & Incident Management: Lead the IT/OT team in managing and resolving incidents promptly, ensuring seamless plant operations and minimizing downtime.
• Support Automation CSV Activities: Support Computer System Validation (CSV) efforts to qualify production lines for the new site, ensuring all automation systems comply with regulatory and operational requirements.
• Vendor Coordination: Partner with equipment and system vendors to qualify and install PLCs, Environmental Monitoring Systems (EMS), Building Management Systems (BMS), and other automation technologies.
• Qualification Protocols: Develop, review, and execute qualification protocols—including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)—in alignment with company and regulatory standards.
• Troubleshooting and Issue Resolution: Diagnose, troubleshoot, and resolve issues during qualification and commissioning phases to ensure timely project delivery and compliance.
• 24/7 Operational Support: Deliver continuous technical support for automation systems post-startup to ensure uninterrupted production and rapid response to system failures.
• IT Systems & Infrastructure: Plan, deploy, and maintain IT infrastructure, including setting up new environments, installing virtual machines, and configuring network switches.
• Cybersecurity: Implement and monitor cybersecurity best practices to protect IT/OT systems, safeguard critical data, and ensure compliance with corporate security standards.

Qualifications

• Bachelor’s degree in Engineering (Electrical, Controls, Chemical, Mechanical, or related discipline) required.
• 5+ years of hands-on experience with control systems, including PLC, DCS, and MES platforms (e.g., Rockwell, Siemens, DeltaV, Syncade) within the pharmaceutical industry.
• Strong knowledge of Good Manufacturing Practices (GMP) and regulatory compliance requirements.
• In-depth understanding of Computer System Validation (CSV) and Commissioning & Qualification (C&Q) processes.
• At least 2 years of leadership experience managing automation teams, with a proven track record of troubleshooting system issues and driving timely resolutions.
• Strong expertise in IT infrastructure design and deployment to support OT systems.

Skills

• IT/OT coordination
• System validation and qualification (CSV, IQ/OQ/PQ)
• PLC, DCS, MES platforms
• Regulatory compliance (GMP)
• Cybersecurity best practices

Education

• Bachelor’s degree in Engineering (Electrical, Controls, Chemical, Mechanical, or related discipline) required

Additional Requirements

• Travel requirements not specified in source
• Location not specified in source