Job Location : Libertyville,IL, USA
The Enterprise Systems and IT Service Support position will be responsible for understanding and supporting the integration between Enterprise IT Systems and Site Manufacturing, Laboratory IT Systems and Data Analytics. This role will support the successful operation of manufacturing and business functions of the Libertyville Facility through interaction with internal team members, Enterprise IT peers and higher-level customers as well as external service providers. The individual supports multiple IT projects/systems and ongoing work activities of moderate to high complexity. The individual will answer questions and resolve Intra-systems integration issues for manufacturing and manufacturing support staff. This role is responsible to support the service management of all the IT systems supporting the manufacturing operations within the Libertyville facility. Develop, deploy, and maintain the IT support structure (ServiceNow Configuration Management, Support Management, Knowledge Management, Book of Work) for the Libertyville facility including but not limited to Automation systems, IT hardware, IT network and Enterprise IT applications. The candidate should have at least 8 years of experience in pharma/biotech with experience in Automation, Manufacturing, Supply Chain and Quality System disciplines. The candidate needs to understand shop floor activities, Good Manufacturing Practices (GMPs), electronic change management, and process automation in addition to prior manufacturing enterprise systems support. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: • Ability to effectively communicate with both technical and non-technical team members. • Strong interpersonal and organizational skills and ability to handle multiple priorities. • Knowledge of IT systems such as ERP, OSI PI, Client, LIMS, ServiceNow, Celdox and Veeva. • Knowledge of various IT Systems integration and Agile Methodologies. • Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices. • Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Cell Therapy or Biologics manufacturing. • Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow). • Strong technical and problem-solving skills and the ability to work independently. • Demonstrated success working in a high-performing, business results-driven environment. • Understanding of computer system validation. • Familiarity with ERP systems (i.e. SAP or QAD), MES systems (i.e. Emerson Syncade), DCS systems (i.e. Emerson DeltaV), OSI PI, EBRs (i.e. InfoBatch) and IT system integrations. • Dashboard development / Tableau knowledge is a plus. Education and Experience: • Bachelor's degree in an engineering or computer management discipline. • Must have experience with Manufacturing IT Systems and Systems Integration. • Must have 8+ years of hands-on experience in a Cell Therapy or Biotech manufacturing and supply chain environment. • Understanding of supply chain, manufacturing domains, and supporting technology like manufacturing and supply chain ERP systems • Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP. • Sound understanding of Electronic Batch Records (EBR). DUTIES AND RESPONSIBILITIES: • Will support the Libertyville Facility Enterprise Systems, Service Management and Agile Methodology. • Partnering with Client CTO Digital Platform, Manufacturing Operations, MS&T, Quality, Enterprise IT teams, Enterprise Business team and local system Digital Capability Managers to deliver the requirements for the Libertyville Cell therapy facility. • Review and collaborate with the Enterprise Digital Capability Manager (DCM), Technical System Owner (TSO), Business System Owner (BSO) and enterprise in understanding maintenance, planned outages, unplanned outages. • Understand the business needs and own the site's enterprise roadmap for IT. • Align the site on future Enterprise IT integrations. • Support the IT tier structure and meetings and represent IT in Tier 2 meetings as applicable. • Manage and maintain the IT Service Management Systems. • Develop and present Libertyville IT metrics.