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Catalent Automation Engineer in Bloomington, Indiana

Job Title:iAutomation EngineerCity: BloomingtonState :INJOB DESCRIPTION:Maintain CGMP operational readiness of automation systems.Design and specify automation/control application software and strategies based on the latest GAMP guidelines.Develop programs, GUI design in accordance with design requirements (Allen Bradley, Siemens Simatic, Siemens Insight and/or Delta V).Configure/replace VFDs, performed hardware/software firmware updates for PLCs and HMIs. Compile/maintain system requirements and detailed design specifications.Interface with engineering, maintenance, manufacturing and other end users of the system and implement necessary changes to improve each systems overall efficiency and quality.Consult with project teams to communicate standards, designed constraints/requirements.Manage all aspects including specification, budgeting, procurement, scheduling, installation, and validation. Per Change Management, develop solutions and implementation and/or test plans to support operational needs.Provide calibration and operational support to Maintenance and Engineering.Update controlled documents as per CGMP/GDP/GAMP guidelines.Identify/generate/review and/or approve automation related change controls, deviations, CAPAs and work orders; determined appropriate system components, regression testing, maintenance, and expansion requirements.Develop and execut (IQ/OQ/PQ) for GMP Automation and Control systems. Support/lead commissioning and qualification activities.Administer automation system user accounts and system security.Configure/maintain software applications including PLC, HMI, data historian, metrics and data reporting tools, alarm notification systems, batch/recipe management, OPC servers and clients.Support operations, product development and quality by providing batch-related and critical operational data.Perform work using one or more of the following Control Systems: Emerson DeltaV, Rockwell/Allen-Bradley Logix-based controllers, OSI PI Historian, Siemens Insight/Infocenter, View ME/SE or GE Unicorn.Work with computer and application validation (GAMP methodology), cGMPs and 21CFR Part 11 in an FDA regulated environment.Understand mechanical layouts and electrical/pneumatic schematics (PandIDs)Develop and maintain PandIDs, electrical drawings.Work in process and batch control, SCADA, OPC, and SQL; experience with S88 and Batch (Deltav V or FactoryTalk)IT competencies to an understanding level: Networking, Firewall, Virtual Machines, MS SQL Database, Backup and restore. Able to troubleshoot issues with servers, switches and networking.Develop understanding of equipment testing (FAT / SAT) and commissioning procedures.Develop and maintained PandIDs, electrical drawings.Interact with customers and understood process design requirements and regulatory expectations.EDUCATION AND EXPERIENCE REQUIREMENT: Requires a Bachelors degree in Electrical, Mechanical or Chemical Engineering and 3 years of experience in job offered or 3 years of experience in the Related OccupationRELATED OCCUPATION: Sr. Engineer or any other job title performing all listed job duties. iii JOB TIME : Full Time

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