Position: 

The Process Automation Engineer is a key member of the site Engineering team, reporting to the Manufacturing Engineering Automation Manager. This role is responsible for supporting and enhancing the site’s Operational Technology (OT) infrastructure and automation systems used in GMP manufacturing. You will provide technical leadership for process control systems, support manufacturing equipment reliability, and lead automation initiatives that improve system performance, data visibility, compliance, and operational efficiency. This role also supports capital projects, including system design review, installation, commissioning, qualification (IQ/OQ/PQ), and lifecycle management. Success requires strong technical expertise, cross-functional collaboration, and structured problem-solving in a regulated environment.

Primary Responsibilities:

• Design, implement, and maintain process control systems in compliance with corporate standards and site GMP requirements.

• Provide technical ownership of DeltaV, PLC, SCADA, and associated automation platforms,

• Lead troubleshooting efforts for control systems, networked devices, and data acquisition platforms.

• Develop and implement system enhancements to improve equipment reliability, throughput, and data integrity.

• Ensure compliance with software lifecycle management, patching strategies, licensing, and cybersecurity standards.

• Support validation documentation including URS, FRS, SDS, IQ/OQ protocols, and change control documentation.

• Integrate manufacturing data sources (PLCs, historians, MES, etc.) to improve operational visibility and reporting.

• Develop monitoring and alerting tools to proactively detect system issues.

• Participate in and support regulatory inspections and audits.

• Collaborate with Corporate IT to maintain secure and compliant OT/IT network integration.

• Provide on-call support for critical manufacturing systems as required

Experience: 

• General: 

  • 5+ years of experience supporting automation systems in a regulated manufacturing environment (pharmaceutical, biotech, medical device preferred).

  • Hands-on experience with DCS and PLC platforms (DeltaV, Rockwell, Siemens, etc.).

  • Experience with system commissioning, loop tuning, and startup activities.

  • Experience supporting GMP change control and validation processes.

• Technical Knowledge

  • Strong understanding of PLC and DCS programming, including ladder logic and function block programming.

  • Knowledge of industrial networking (TCP/IP, VLANs, firewalls, managed switches).

  • Experience with data historians, SQL databases, and manufacturing data integration.

  • Familiarity with 21 CFR Part 11, data integrity principles, and GMP automation requirements.

  • Experience with SCADA system configuration and maintenance.

  • Understanding of ISA-88 batch control concepts (preferred).

• Behavioral Competencies

  • Demonstrated ability to lead technical problem-solving efforts.

  • Strong communication and cross-functional collaboration skills

  • Ability to prioritize and manage multiple projects in a fast-paced GMP environment.

  • Proactive mindset with focus on continuous improvement.

Education: 

• Bachelor’s degree in Electrical Engineering, Computer Engineering, Computer Science, or related technical field required.

• Equivalent combination of education and relevant experience may be considered