Automation Engineer

Position Summary The Automation Engineer is responsible for overseeing the health of the automation processes. This includes overseeing design and fabrication of new equipment, modifications to existing equipment, continuous improvement to existing systems, and troubleshooting/repair on existing systems. The Automation Engineer is also responsible to manage the manufacturing risk through strong equipment and process designs, strong validations, and strong life cycle oversight to production and quality metrics. This position will work collaboratively with all departments and have high involvement with the Production and Quality.

Key metrics:

Machine Efficiency, Scrap, mean time between interruptions, cost savings, and customer complaints. Job Responsibilities Oversee software revision on automation equipment. Assist in software validation for control systems. Generate documentation and equipment specifications for new and existing equipment. Execute automation equipment validation protocols to test and challenge the processes. Understand PLC ladder logic with the ability to troubleshoot existing programs and write new programs for conveyor systems. Experience in working with IT systems that support automation such as MES and CMMS. Write work instructions for operators to interface with automated equipment. New production process setup

• oversee process development, design of experiments, and process setup workbook. Change Management
• evaluate the impact to product, processes, and equipment changes on critical attributes and product performance. Commissioning, Qualification and Validation
• provide Engineering support and oversight for new processes and process changes. Quality by Design (QbD)
• participate in the definition of user requirements and ensure they conform with company processes and regulatory guidance. Critical process parameter (CPP/CQA)
• assure CPP/CQAs are defined and understood and incorporated into design and control functions. pFMEA
• facilitate team exercises to evaluate and identify potential failures modes, risk, and opportunities related to operational processes, and develop control plans.

Other duties as assigned by management. Experience Requirements Must possess strong knowledge of industrial automation equipment. Working knowledge of PLC control systems and HMI interface. Ability to review mechanical design for equipment. Experience with OPC/UA interface between equipment or to upload machine information. Must be detail-oriented with exceptional planning and organizational skills. Proficient in office software programs such as word and excel. Understand 21 CFR part 11 and working knowledge of GAMP 5 requirements. Must be an effective communicator both up and down the organizational structure. Mentoring and training of new employees is an essential skill for this position. Minimum 3 years experience in a manufacturing environment, preferably in a regulated environment such as 21 CFR, ISO 13485, or

IATF 16949.

Must be able to sit and/or stand for extended periods of time, Must be able to climb stairs, must be able to lift and carry 25 lbs, and walk while carrying items. Education Requirements Bachelor's degree preferred in a scientific discipline or related field. A combination of education and relevant work experience may be acceptable in lieu of a degree.