- March 16, 2022
- Automation, Engineering, Greater Solano County Area, CA, Pharmaceuticals
5003 Automation Engineer IV
Duties
Provide automation support to Vacaville Manufacturing Operations for technology transfer recipe deployment and operational support, focused on the Manufacturing Control System (MCS).
Responsibilities include:
Provide automation design and support for the MCS, including integration with PLC systems.
Work with Manufacturing, Quality, and Engineering departments to implement process design solutions.
Assist with automation testing, debugging, and startup activities.
Perform Quality discrepancy evaluations/assessments and provide support for Investigations.
Perform troubleshooting of process, equipment, and system malfunctions or failures involving the MCS system, including after-hours on-call support.
Perform off-line and online coding, testing, and peer reviews.
Develop automation functional-specific documents.
Review, and revise automation documents.
Represent automation engineering on multidisciplinary and cross-functional project teams.
Support and/or lead development and execution of automation change records (CRs and ACRs) and execute control qualification/commissioning test documentation
Provide consultation for more junior automation engineers on technically challenging issues.
Skills
A minimum of 9 years of experience in the design, implementation and/or support of instrumentation and control systems, preferably in the Bio-Pharmaceutical or Pharmaceutical batch processing industries.
Must have experience with distributed control systems, software development methodologies and automated system life cycle support in a regulated industry, specifically with Honeywell Experion PKS TotalPlant Batch, and POMSnet is highly desired. Experience with DeviceNet and Allen-Bradley ControlLogix is a plus.
Familiarity with Instrumentation, Systems, and Automation Society (ISA) Standards S88 and S95 as well as the International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice (GAMP) Guide to the Validation of Automated Systems.
Thorough understanding of cGMPs particularly as they relate to the operation, validation and maintenance of computer-controlled systems.
Education
BS degree in Chemical Engineering, Electrical Engineering, Mechatronic Engineering, Computer Science, or combination of equivalent training and experience.