MES Engineer (Syncade) at Pharmatek Consulting Inc

MES Engineer ( 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

• 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