Job Description: Job description:
- The Lead automation engineer will be responsible to support the operations on all GMP manufacturing systems (Process Automation System) in the Manufacturing Facilities in Devens, MA.
- Lead as well as 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.
- Lead the Devens DeltaV systems upgrades, virtualization, system management including (patching, hot fixing and maintaining them up to date)
- 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.
Knowledge and Skill Sets:
- BS in Chemical Engineering/ Electrical Engineering or any related equivalent engineering field or equivalent experience.
- 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.
- Understanding of DeltaV systems administration work for database, applications, upgrade, virtualization, etc. 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.
Additional Sills: