
Senior Specialist DDIT OPS, Automation Engineer
- USA
- Permanent
- Full-time
- 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.
- 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.