Sr. Associate Digital Manufacturing - (JP11833)

• Provides technical support, project management, and troubleshooting assistance of various smart manufacturing technology and computerized systems within the manufacturing area (e.g. AR/VR Technology, MES, ERP, SCADA, Systech, Serialization).
• Support the site in the project approvals, prioritization, and manage the roll-out and implementation of smart manufacturing technology concept initiatives for the manufacturing area.
• Support the business with the implementation of data analytics, reporting and provide insight in business critical KPIs and OEE (e.g. KPI tools, OEE, Spotfire).
• Support Client’s Ohio manufacturing team during troubleshooting for key computerized systems and assist during problem solving.
• Act as manufacturing business representative in cross-functional meetings and support all levels of the organization to drive digital manufacturing projects.
• First line Subject Matter Expert (SME) for smart manufacturing technology, computerized systems, and MES and ERP.
• Assist in global harmonization strategic activities for digital manufacturing which include but not limited to design, improvements, system configuration, validation, and investigations.
• Support digital manufacturing lifecycle management and represent team during software or system upgrades.
• Generate, and review documents (SOPs, FORMs, Deviations, CAPA, CC, etc.) associated and owned by digital manufacturing team.
• Work with team to ensure training on new or revised digital manufacturing processes is effective and completed for end-users (Operators/Supervisors/Technical/QA/Support Staff).
• Uses the latest data analysis tools and methodologies to solve systematic problems and improve process efficiencies to maintain production schedule adherence.
• We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a collaborative partner with these qualificatio

• Educational Background or experience in Science, Pharmaceuticals, Biotechnology, Digital Technology, and/or Engineering.
• Experience with data analytics, process performance and reporting tools (e.g. KPIs, OEE, Spotfire).
• Experience with design, configuration, qualification/validation in smart manufacturing and computerized systems and system integration supporting manufacturing and the end user e.g. MES, ERP, SCADA, Systech, Serialization.
• Experience in a GMP environment and background in smart manufacturing technologies and computerized systems and comprehensive understanding of the Manufacturing process with the ability to translate to an Electronic Batch Record.
• Analytical fact-based problem solver and strong troubleshooting skills on process, equipment, smart technology, and computerized systems.
• Ability to maintain an environment and culture of operation excellence, continuous improvement, and lean manufacturing (Kaizen process improvements).
• The ability/experience working in fast paced manufacturing environment where issues must be assessed, understood, and resolved immediately to be able adapt quickly to the demands of commercial manufacturing operations.
• Experience in deviations, investigations, root cause analysis, CAPA’s and change controls.
• Pro-active, result oriented, and ability to prioritize work to meet timelines.
• Good documentation practices and skills including technical writing
• Good communication skills to all levels of the organization.

• Being Tech savvy - should be able to easily pick up new systems (please see above. person should ideally have experience in at least 1 of the systems listed).
• Experience working in a GMP environment and having GMP experience.
• Being able to work with cross functional teams in a dynamic and continuously changing environment.

Salary : $33 - $38