Job Description

Description

The Automation Engineer supports automation and control systems at the Aldevron, Fargo Manufacturing site. This role also provides technical automation support to ensure operational success of manufacturing and other associated departments. Additionally, the role will be to support day-to-day troubleshooting and problem-solving activities associated with existing site and equipment-based control systems.

Responsibilities

Identify and actively pursues opportunities for efficiencies in automation work processes
Review/evaluate the maintenance and upgrades of cGMP software administration programs
Provide leadership, automation support, and troubleshooting to Manufacturing, Quality Control, Validation, and Facilities according to established SOPs and departmental practices
Perform investigations relating to manufacturing deviations and excursions associated with automation systems and control system software
Develop and edit engineering design documents, technical evaluations, and test plans for cGMP process equipment and follow GAMP 5 guidelines as they relate to assigned projects
Support manufacturing activities with process control and process monitoring equipment software design, commissioning, and testing to meet end user requirements
Support automation activities by updating or authoring system specifications, user and functional requirements specifications, generating and executing necessary FAT and SAT protocols
Support manufacturing process control projects related to corrective action, equipment performance improvement, and new equipment
Design, develop, and implement software/hardware improvements to automated process control and process monitoring equipment according to change control procedures (PLC's and HMI's)
Assist with or lead developing standard operating procedures for the use and maintenance of automated systems
Provide oversight on automation aspects of future projects including integration of 3rd party equipment to the plant SCADA and BMS systems, data concentration, batch reporting, and data retention
Maintains, troubleshoots and modifies the GMP and non-GMP control systems
Participate and/or lead new product implementation product transition processes to ensure smooth transition from process development into GMP manufacturing
Problem solve technical issues impacting production.
Support 24x7 site-based operations after startup
Analyze and interpret data and make sound technical recommendations on continuous improvements and non-conformance remediations
Support data integrity and computer system validation of automated manufacturing equipment
Work collaboratively with Validation department to design, conduct, and develop reports for experiments to characterize and validate new or changed equipment programming

Required Skills

Knowledge of Allen-Bradley and Siemens PLC control systems (RSLogix 500/5000 and S7/TIA Portal) required.
Knowledge of industrial communication networks (e.g. AB DeviceNet, Ethernet IP, Profinet, field bus networks, RS-232)
Skilled at troubleshooting PLCs and HMIs and systems in a pharmaceutical or biopharmaceutical manufacturing facility
Basic understanding of bioprocessing equipment design principles, sanitary equipment design requirements, and data integrity regulations
Experience programming, troubleshooting, and maintaining site SCADA/HMI systems (e.g. FactoryTalk View SE, iFix, Wonderware, Emerson/DeltaV)
Experience programming, troubleshooting, and maintaining site PLC/BMS systems (e.g. ControlLogix, Siemens TIA/S7).
Able to develop MS SQL queries
Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high quality driven processes and end products
Demonstrates skills in requirements gathering, design, configuration, integration, and implementation of process control solutions for the manufacturing industry including batch software, PLC based control systems, HMI packages, building management systems, SCADA systems, and PC networking technology
Excellent verbal and written communication skills
Must be self-motivated and possess an independent work style
Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership
Analytical and problem-solving skills are required
Knowledge of GMP’s and regulatory requirements for biologics manufacturing
Ability to effectively organize and work in a fast-paced, multitasking, deadline-driven work environment under pressure.
Ability to lead in a strategic thinking and analytical manner, with a strong ability to translate these and implement operationally
Ability to troubleshoot issues

Must-Haves

B.S. degree in electrical/industrial/automation engineering or equivalent (5-10 years field automation experience)
Minimum 5 years of experience in automation programming
Experience in computer networking and validation preferred
Experience in manufacturing is required, biomanufacturing is preferred
Minimum 5 years of experience in automation programming

Valid through: 3/10/2021