Automation and Controls Engineer with FDA Regulated Industry Exp.

Position Summary

This position is responsible for the design, development, programming and implementation of process control systems for pharmaceutical manufacturing processes and plant facilities for full compliance with FDA regulations. Support the facility, utility, manufacturing and packaging related control systems. Troubleshoot control and instrumentation systems and resolve discrepancies. Work with equipment vendors on purchases. Programming, installation and configuration of automated systems. Develop and execute test strategies, prepare and execute protocols, analyze results using statistical methods, prepare technical reports and write standard operating procedures. Participation on cross-functional teams to coordinate control related activities with external consultants, contract validation services, Process Engineering, Facilities Engineering, Manufacturing, and/or Quality. Support and perform calibrations.

Required Skills & Experience:

BS or Technical degree in engineering controls or a related field with 5-7 years of experience or MS/MBA with 3-5 years of experience or the equivalent combination of training and experience.
In-depth knowledge of PLCs, SCADA, HMIs, Vision system, Robotics and Visual Basic.
Proven ability to program PLCs, HMIs.
Effective project management skills.
Working knowledge of ControlLogix, Panelviews, RSView SE, RSBatch, Assest Centre, FactoryTalk, EPAS-4 and Wonderware a plus.
Understanding and knowledge of networks used in Manufacturing such as EtherNet, DeviceNet, Foundation Fieldbus, and others.
Experience operating, qualifying or developing batch processes, pure water systems, compressed air systems, HVAC systems, Filling Units, Lyophilizers, Freezers and Refrigerators a plus.
Understanding and knowledge of ISA S88 and S95.
Some knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory expectations and industry trends.
Experience working in a FDA regulated industry - knowledge of cGMPs, GAMP & 21 CFR part 11 validation requirements.
Strong technical writing, verbal communication, interpersonal and problem-solving skills is required.
Must exhibit proven ability to work independently and manage assignments cross-functionally.
Working knowledge of historian data storage such as Wonderware InSQL, Factorytalk Historian, and query programs for real-time control systems a plus.
Working knowledge of Microsoft Word®, Excel®, Visio®, PowerPoint®, and AutoCAD®.