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26 days old

Automation Engineer (cGMD, GAMP5)

Kelly Services
Prairie Rose, ND 58104
I have an exciting **Direct Hire** opportunity for an **Automation Engineer (cGMD, GAMP5)** with a Client located in **Fargo, ND.**


A manufacturing site who is Advancing Science that provides high-quality plasmid DNA, proteins, enzymes, antibodies, and other biologics to help our partners achieve significant breakthroughs for a variety of life science applications and has grown into a world-class service organization specializing in nucleic acid and protein production, antibody development, and custom services with operations in the United States and Europe.


**What you will need for this role:**


+ 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 GMPs 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


**In this role you will:**


+ Identify and actively pursues opportunities for efficiencies in automation work processes

+ **Review/evaluate the maintenance and upgrades of cGMP software administration program** s

+ 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 remediation's

+ 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


**Benefits beyond a paycheck:**


+ Health Insurance

+ Vision

+ Dental

+ Health Savings Account

+ Flexible Spending Accounts for Medical and Dependent Care

+ Life Insurance

+ Short Term and Long Term Disability coverage

+ Employee Wellness


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-24 Expires: 2021-10-25

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Automation Engineer (cGMD, GAMP5)

Kelly Services
Prairie Rose, ND 58104

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