Sr. Engineer II, Automation

Role Summary

Senior Automation Engineer II responsible for supporting automation systems essential to biopharmaceutical manufacturing processes, including operating PI, Infobatch, and related data systems; managing system lifecycles; collaborating across teams; and ensuring compliance and operational excellence.

Responsibilities

• Provide technical ownership, administration, and support of PI, Infobatch, and other data systems across development and GMP manufacturing environments.
• Collaborate with cross-functional teams‚Äîincluding Process Development, Engineering, Manufacturing, Quality, and IT‚Äîto integrate automation platforms into broader business and compliance workflows.
• Lead or support projects involving data acquisition system upgrades, software validation, alarm monitoring improvements, and batch reporting enhancements.
• Ensure system reliability, data integrity, and compliance with 21 CFR Part 11 and other applicable regulatory requirements.
• Lead troubleshooting and root cause investigations related to system and equipment data capture, alarms, and reports.
• Support development and maintenance of user requirements, functional specifications, system validation, and standard operating procedures.
• Serve as a subject matter expert (SME) for audits and inspections related to automation systems.
• Mentor junior engineers and provide technical guidance on best practices and system usage.

Qualifications

• B.S. in Engineering
• 6+ years of experience working with manufacturing systems in biopharmaceutical manufacturing environments.
• Hands-on experience with: PI (tag configuration, Asset Framework, visualization tools such as PI Vision)
• Solid understanding of GMP regulations and experience working in validated systems.
• Experience supporting system lifecycle management, including upgrades, backups, disaster recovery, and cybersecurity controls.
• Excellent troubleshooting skills and ability to work independently in a fast-paced environment.

Preferred Qualifications

• Experience working with automation systems such as MES (Syncade), DCS (DeltaV), and SCADA (Rockwell) platforms.
• Infobatch (batch data reporting, SFO/recipe integration)
• TopView (alarm notification setup and system management)
• Knowledge of IT/OT networking and virtualized infrastructure (Nutanix).
• Experience with scripting or programming (e.g., VBA, Python, SQL) is a plus.