MES Syncade

Lead Automation Engineer ( MES Syncade )
Location: 50% Onsite , Devens MA, 50% Remote
Duration: 10 months extendable

Responsibilities:

Convert our Single Use Facility (SUF) from Paper Batch Record to electronic batch record using MES 3.0.
Convert our MES 1.x in LSCC to MES 3.0 as part of MES NextGen project.
Author, edit, and review CSV life cycle documentation (VP, RA, RCA, TM, VSR) and system specifications (URS, FRS, DS, CSs)
Design and deploy equipment that is of intermediate to high complexity. Generally, responsible for all aspects of automation for assigned project(s)
Programs (custom) and configures for all products including highly custom equipment
Develops and tests new features requirements for next generation products
Dives into design programming, sequencing and electrical signaling issues to resolve complex automation design challenges
Troubleshoots and tests higher complexity PLC programming
Reviewing functional specifications for both hardware and software for new automated utility, process, filing, and packaging and inspection equipment
Preparing a preferred vendor list for control system hardware
Specify and troubleshoot instrumentation
Perform duties of client Automation Department representative on a capital project




Candidate Requirements

50% onsite requirements
Must be able to work onsite in Devens, MA
Demonstrated work history as a Senior Automation Engineer
Bachelor’s Degree (Engineering or Scientific). Preferred area of study in Electrical Engineering Technology, Computer Engineering, or similar study
Experience working with and programming/commissioning/validating MES software platforms
Exposure to FDA regulated environments including validation experience
Understand 21 CFR Part 11, GAMP 5, and other regulatory guidance associated with computer/automation based systems
Previous project management experience
Experience with OSI PI