MDPI Equipment Engineer
o Bachelor's Degree in a science or engineering related discipline
o 5 years detailed experience delivering mechanical and/or automation projects, technologies and troubleshooting within the Pharmaceutical industry.
o Ability to interface with operational, technical, supervisory and senior management within the organization.
o Ability to work with minimal supervision on a regular basis
o Technical expertise in several scientific, engineering and/or 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 project qualification execution, including software testing, loop checks, and various other FAT, SAT, commissioning and qualification procedures.
o A sound scientific and engineering understanding of pharmaceutical secondary processing, preferably
in a manufacturing environment.
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 Solid experience in capital project management, including equipment and system validation lifecycle
development and execution, project budget management, resource planning and schedule management.
o Working knowledge and understanding of EHS Practices with respect to the installation of production equipment, facilities and control systems.
o Proven track record in providing technical support and maintenance for mechanical equipment, instrumentation, automation and controls.
o Excellent written and oral communication skills
To execute the major elements of the site strategy and provide mechanical and automation expertise to the Zebulon site within a multi-disciplinary and extended stakeholder team including Production, Technical, Engineering, Maintenance, Quality, Facilities, Automation, and EHS; as well as external contractors and consultants. To successfully deliver continuous capital projects which drive the Zebulon True North Strategy, to include measurable deliverables in the areas of Quality, Safety, Sustainability, and Security of Supply. Provide day-to-day production support at the shop floor level, with a strong emphasis in mechanical, automation, instrumentation and controls troubleshooting; both for new and existing pharmaceutical production equipment, as well as peripheral support systems as business drivers dictate.
o Maintain a detailed and expert knowledge of current and future innovative and diverse pharmaceutical platform technologies, with a strong emphasis in high level automation and control systems as well as cutting edge mechanical processes and systems.
o Responsible for the delivery of continuous improvement projects to meet business requirements in terms of functionality, cost, quality and schedule adherence.
o Partner with maintenance and production stakeholders to assist in day-to-day troubleshooting of production related issues as required.
o Provide process expertise and lead EHS assessments where appropriate. Ensure compliance with all role-related GSK policies, procedures and local codes.
o Interface and build robust partnerships with key site stakeholders including Production, Maintenance,
Technical, Planning, Facilities, EHS, Automation and Quality to ensure projects deliver agreed
o Actively participate in area extended management teams, EIT's, technical investigations and multidiscipline project teams as necessary; while actively managing multiple projects simultaneously.
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 Ensure performance management systems are in-use (GPS and Standard work) to manage individual
and team priorities and responsibilities.
o Mentor fellow engineering, maintenance and technical stakeholders in mechanical and automation technologies and applications.
o Provide subject matter expertise (SME) in regulatory inspections and interact with auditors as
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