1827 Automation Engineer IV
Serve as an SME for the Autoclaves, Washers and CIP equipment (including the CIP Supply/return distribution).
Provide mechanical and automation support for the day-to-day Make / Assess / Release and Project Support activities.
Develop, review and approve applicable mechanical and automation-related specifications and any other related documentation.
Perform Quality and Safety Assessments within the existing Quality Management System working with CAPAs and Tracking Actions.
Prepare, review and approve Qualification and Debug protocols for the CIP, Autoclaves, Washers, Powder and Liquid Aliquot dispensing systems.
Prepare and coordinate the approval and execution of Change Requests and Automation Change Requests (ACRs).
Conduct GEMBA walk-downs and visual assessments of the areas, and address emergent issues / troubleshooting.
Review and update I/O drawings, requirements specifications, design specifications and wiring and integration diagrams and documents of Washer and Autoclave.
Review and Update P&IDs, prepare mechanical equipment Data Sheets and specifications.
Provide data extraction from PI system, and the data analysis for the performance of the Washers, Autoclaves, Dispensing Systems, and CIP equipment.
Support design, development and execution of Automation Change Records (ACRs) and control qualification/commissioning test documentation.
Perform detailed reviews of executed ACRs and tests for completeness and accuracy.
Generate test documents for I/O, loop checks and sequence tests of Washer and Autoclave.
In coordination with Instrument Services and Electrical groups, execute I/O, loop checks and sequence tests.
Perform troubleshooting of process, equipment, and system malfunctions or failures involving the PLC.
Perform Data Integrity assessments for the Washer and Autoclave PLC systems.
Provide automation support for the execution of IQ, OQ and PQ activities for CIP equipment/systems, Washers, and Autoclaves as well as powder and liquid aliquotes dispensing equipment.
12-15 years of hands on Automation/PLC experience in a GMP Biotech/Manufacturing facility is required.
Please do not apply without this experience.
Experience reading and understanding wiring diagrams, I/O diagrams and P&IDs.
Experience in preparing mechanical equipment Data Sheets and Specs.
Experience with Quality Management records and assessments that includes CAPAs and Quality Tracking Actions.
Experience creating and executing test protocols for I/O, loop checks and sequence tests.
Thorough knowledge of Good Manufacturing Practices (cGMPs), S88 and GAMP, particularly as they relate to the operation, validation, and maintenance of computer-controlled systems.
Solid understanding of basic engineering techniques and principles and the ability to apply that knowledge as required.
Experience with data analysis and equipment and instruments troubleshooting.
Experience implementing and supporting data integrity requirements.
Experience with Computer Systems Validation.
BS or MS Degree in Chemical, Electrical Engineering or equivalent training.