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Compliance Automation Engineer

Company: Verista
Location: Kalamazoo
Posted on: February 23, 2021

Job Description:

Verista's 350+ experts team up with some of the world's most recognizable brands in the pharmaceutical, manufacturing, and food and beverage industries. From compliance to testing, validation, automation, manufacturing and packaging, we bring you solutions you can trust - every time.Job FunctionCompliance Automation EngineerThis position requires advanced learning; technical precision; and consistent use of independent judgment and discretion. Automation Engineers design, develop, program, test and support automated manufacturing equipment, vision systems, and custom equipment used in Industrial manufacturing and packaging operations.The Compliance Automation Engineer will participate as a professional engineering team member on projects with responsibility for equipment design, programming, start-up, and validation for high speed automated manufacturing and packaging equipment. The Compliance Automation Engineer will provide strategic and tactical direction on the compliance aspects of all digital systems.Compliance duties include negotiating strategies with quality, leading data integrity assessments, updating and creating strategic standard operating procedures, implementing new methodologies, and mentoring automation engineers in compliance methodology as well as audit representation for automation systemsPrimary Duties and Responsibilities* Improving the compliance footprint for the automation organization by implementing continuous improvement practices for the automation team to follow related to regulatory, corporate, and site policies and practices.* Preparation and representation for automation in regulatory and customer audits.* Communicating and collaborating with operations and automation colleagues to manage and/or perform user account reviews* Updating Data Integrity Assessments and routing them through change control* Performing/managing records retention tasks* Managing automation department compliance methodologies, strategies, systems and standards including Data Integrity, SOP periodic review, CAS reviews, and other documentation.* Assisting Cybersecurity lead with strategy, methodologies and documentation of process and procedures from a compliance perspective.* Assisting Infrastructure lead with strategy, methodologies and documentation of process and procedures from a compliance perspective.* provide 24x7x365 support of our automation systems from a compliance perspective including assisting automation engineers when emergencies arise to have issue properly addressed and documented.* Participate in the Engineering Compliance Services team representing automation.* Review system support documentation to ensure compliance* clearly communicate progress and issues to peers and management* Assist in training and mentoring site Automation Technicians, Analysts, and Engineers.* Monitor and trend issues to identify and develop preventative solutionsQualifications* Bachelor of Science degree in a technical field such as Electrical, Mechanical, Chemical, or Computer Engineering, or Computer Science.* 9 or more years of Automation Engineering experience.* Proficiency in Excel, Word, Powerpoint, Sharepoint, Teams* Good Organizational skills and can meet project task deadlines* Proven ability to work in team environment and contribute as a team member* Ability to learn new technologies and adapt to changeRequired Skills* Visual Basic scripting* Cognex VisionPro toolset programming (for equipment engineers)* Programming -Visual Basic* PLC programming* Electrical schematic design and development in AutoCAD or equivalent program* Technical understanding and experience with automated equipment for manufacturing, device assembly, and packaging (PLCs, HMIs, PC based controls).Experience and ability to read, trace and troubleshoot equipment design and start-up using electrical, mechanical, P&ID (piping and instrument) and facility drawingsPreferred Qualifications* The ideal candidate should have background in cGMP regulations and the practical application of those methodologies to control systems.* System technical knowledge, such as MS Windows Server, Active Directory, SQL Server, VMware, vSphere, vCenter, Cisco, Networking and OSI PI.* Experience building systems and installing patchesSupervisor RequirementsThis position requires a cross-functional working relationship with peer engineers, clients, OEMs, and contractors in orders to meet project goals and deadlines.This position does not have any direct report responsibilities.Work Environment and Physical DemandsFLSA professional position paid on salary basis, where project requirements and tight client deadlines may require workweeks in excess of 40 hours (including weekends or holidays)* Work is often performed at our Fishers Headquarters (25% travel) with PPE required at some customer locations and indirect exposure to drug products at some customer locations.* Many client sites require specific safety training and adherence to OSHA requirements.* Work is performed in and around automated equipment, and cabinets in a manufacturing environment which requires standing, crouching, reaching and leaning over to work on and inspect equipment from many angles.* Lifting requirements - 35 lbs. per OSHA requirements* Walking (including in/around automated equipment and electrical cabinets) 1-2 miles is possible (carrying laptop and materials)

Keywords: Verista, Kalamazoo , Compliance Automation Engineer, Engineering , Kalamazoo, Michigan

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