Pharmatek Consulting Inc.
Devens, United States | Posted on 05/12/2024
Industry Pharma/Biotech/Clinical Research
Job Type Contract
Work Experience 5+ years
State/Province Massachusetts
Country United States
Job Description
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 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
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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 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
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