Overview
Skills
Job Details
Job Responsibilities include:
1) Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
2) Support projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility.
3) Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
4) Development of detailed specification, engineering documents, SOP and computerized system administration job plans. Testing of automation-based process equipment.
5) Ownership and administration of process control automation in a GMP regulated manufacturing setting. Engage in process change control requests per established SOP and processes.
6) Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to mechanical, electrical, instrumentation and control systems.
7) Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.
8) Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
9) Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations