Automation Engineer (Senior Level)
o Bachelors Degree in a Science or Engineering related discipline
o 7+ years detailed experience delivering Automation technology within the Pharmaceutical industry or equivalent years of experience and education with Advanced Degree
o Must include hands-on programming and trouble-shooting skills for Automation, Instrumentation and IT systems
o Ability to interface with operational and senior management within the organization.
o Understanding of FDA PAT initiatives and the impact on the Pharma industry.
o Six Sigma and Lean Manufacturing experience; Black Belt or Green Belt desirable
o Technical expertise in several scientific and engineering automation areas including ISA standards, P&ID nomenclature, instrumentation and electrical wiring diagrams, communication networks, control panels, HMI, MES (Propack, Aspentech), SCADA (RSViewSE, iFix, Wonderware) and PLC (Rockwell, Siemens) Programming, Historians (Aspentech) and SAP.
o A sound understanding of Software testing (FAT / SAT) and commissioning procedures.
o A sound scientific and engineering understanding of pharmaceutical secondary processing, preferably in a pilot or manufacturing environment.
o Good knowledge of IT architecture management, data warehousing & implementation processes.
o Broad and in-depth knowledge and practical experience of computer and application validation (preferably using GAMP methodology), cGMPs, and 21 CFR Part 11 in an FDA regulated environment.
o Demonstrated project management skills
o Working knowledge and understanding of EHS Practices with respect to the installation of automated plant.
o A good appreciation of FDA PAT initiatives and the impact on the Pharma industry.
o SPC techniques and applied application to improve / measure product manufacturing and quality.
o Proven track record in providing automation support and maintenance for instrumentation, automation and controls.
o Excellent written and oral communication skills
To execute the major elements of the site Automation Strategy and provide Lead Process Automation expertise (Pharmaceutical Fill/Finish/Packaging) to the Zebulon site within a multi-disciplinary and extended team of Automation, Instrumentation, IT, Control engineers, external contractors and consultants. To successfully deliver compliant (financial, regulatory (e.g. cGMPs), GAMP) instrumentation, automation, business and control systems for new and existing pharmaceutical facilities, Building Management Systems and Environmental Monitoring Systems at Zebulon.
o Maintain a detailed and expert knowledge of current and future automation technologies and be the site expert in a minimum of 3 of the following disciplines: Field Instrumentation, PLC, SCADA, Historians, Manufacturing Execution Systems, Virtualization and Integration Technologies – middleware, OPC, XML.
o Responsible for the delivery of high value automation projects to meet business requirements in terms of functionality, cost, quality and time.
o Provide process automation expertise and lead safety assessments where appropriate. Insure compliance with all role related GSK policies, procedures and local codes.
o Interface and build robust partnerships with key site functions including Production, Technical, Planning, Engineering and Quality to ensure technology designs deliver agreed benefits. Participate on area extended management teams as necessary and actively manage automation group requests from the business for support or new projects.
o Interface and partner with the GSK community of Shared Services, Centers of Excellence and other sites to contribute, share, and leverage technology and maintain standards as appropriate.
o Insure performance management systems are in-use (Standard work) to manage individual priorities and responsibilities.
o Deliver measurement and control of Quality Critical Attributes (QCA) and help develop the associated Process Critical Control Points (PCCP) through use of appropriate control systems to ensure predictable and stable process operations
o Provide training and support for onsite Users / Engineers in Automation technologies and applications.
o Provide subject matter expertise to regulatory inspections and interact with auditors as necessary.
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