Senior Automation Engineer (DeltaV)

Role Summary

Senior Automation Engineer (DeltaV) responsible for supporting GMP manufacturing automation systems including DeltaV distributed control systems at the Devens, MA facility. Lead and participate in automation engineering initiatives for manufacturing operations, system enhancements, and site expansion activities for clinical manufacturing and biologics development operations. Collaborate with cross-functional teams to define design requirements, test plans, and ensure compliant, well-documented automation solutions.

Responsibilities

• Support operations on all GMP manufacturing systems (Process Automation System) in the Manufacturing Facilities in Devens, MA.
• Lead and participate in automation engineering initiatives in supporting manufacturing operations, system enhancements and site expansion activities for Clinical manufacturing and Biologics development operations. The activities will involve design, configuration, integration, test process control systems.
• Participate in cross functional teams (system integrators, contractors, end users) to develop the design requirement specifications, test plans and protocols. This includes design specifications, functional specification, FAT protocols, SAT protocols.
• Plan, implement and test design following good automation practices and standard operating procedure.
• Provide support to shift engineers in troubleshooting and guide in resolution for manufacturing activities.
• Troubleshoot control systems from field devices up to operator interfaces and databases.
• Work in collaboration with Validation, Quality and Manufacturing Engineering and Manufacturing operations to keep the operations on site functional.

Qualifications

• Minimum 9 years of industry experience on DeltaV distributed control systems.
• Minimum of 2 years of experience in Pharmaceutical or Biotechnology industries.
• In-depth understanding of ISA S88 and batch processing operations required.
• Experience on Manufacturing Execution System (Syncade) preferable.
• Experience on OSI PI data historian applications is preferable.
• Experience on automation validation (DeltaV, MES, PI) in GMP environment that includes test script generation and execution.
• Experience in executing Factory Acceptance Tests, supporting commissioning activities (hardware loop checks, cabinet testing) required.
• Experience on change control management, deviation logs, and investigation under FDA regulated environment is required.
• Understanding of engineering documentation such as P&IDs, Process Flow diagrams and standard operating procedures.
• Strong interpersonal skills and ability to work in a team environment.
• Strong communication skills including oral and formal presentations.
• Ability to work in fast paced multi-tasking environment.
• Ability to troubleshoot control systems from field element up through operator interfaces and databases is preferred.
• Ability to work with visual basics scripting is preferred.
• Ability to work independently.

Education

• BS in Chemical Engineering, Electrical Engineering, or a related engineering field.

Additional Requirements

• On-site presence: Site-essential roles require 100% onsite shifts at the assigned facility; site-by-design roles may be eligible for a hybrid work model with at least 50% onsite. Field-based roles require travel to visit customers, patients or business partners and to attend meetings as directed.