Digital Record Design Hub Lead, Manufacturing Execution Systems Biologics Drug Substance- Ireland

Job Description

We are seeking a proactive and innovative leader to join our Manufacturing Value Team (MVT) within our Digital Manufacturing Division organization, based in Red Oak, Ireland.

Manufacturing execution is a core enabler of our digital manufacturing strategy within our Digital Manufacturing Division organization which creates and realizes business value leveraging digital technologies.

The Digital Record Design Hub Lead within the Manufacturing Value Team (MVT) will lead multiple sites in the Manufacturing Execution System (MES) Digital Record Design Hub (DRDH), responsible for authoring, maintaining, and optimizing manufacturing batch records across the network, including clinical, commercialization, and commercial production digital records. Reporting to the Global DRDH Lead, this role will collaborate closely across the Digital Manufacturing Division and Manufacturing Division to ensure effective delivery, maintenance, change execution, and continuous improvement of electronic manufacturing batch records. Working internationally across multiple organizational levels, from tactical and technical to senior strategic, the role will help drive productivity, enable innovation, and support digital excellence across the manufacturing network.

• →Develop and execute a maintenance plan to deliver change execution windows in line with business requirements to ensure continuous process improvement.
• →Execute a standard process to deliver end-to-end management of the digital record development and lifecycle.
• →Manage a regional team of people, including performance and career management, in addition to third party contractors and vendors.
• →Closely collaborate with the Digital Manufacturing Division Manufacturing Value Team, specifically the Manufacturing Execution System Product team to co-develop and execute on a multi-year, multi-site strategic roadmap, representing the views of the MVT organization and end users at the sites. Work closely with the sites in the region and disciplines such as Technical Operations function in Global Science, Engineering, Commercialization (G-SEC) to ensure production process understanding across our major products.
• →Vendor management to incorporate commercial and technical / product development aspects.
• →Maintain and develop a network of System Integration partners.
• →Collaborate with other products to enable fit for purpose Manufacturing Execution System data integration strategies including process control, production optimization for OEE and plant scheduling.
• →Drive implementation standards and delivery roadmap.
• →Work closely with SAP team in advancing the managing and advancing the Manufacturing Execution System – SAP integration.
• →Facilitate Manufacturing Execution System Subject Matter Expert networks across the region.

• Bachelor’s degree (Bachelor of Science preferred)

• 5+ years of MES working experience in manufacturing life sciences.
• Technical depth with Werum/Koerber PAS-X
• Previous working experience managing people.
• Strong understanding of operational technologies in life science manufacturing specifically the business use cases and value drivers for process execution solutions

• Organizationally savvy – Ability to navigate cross functionally within our Company. Must partner effectively with all levels of leadership.
• Builds networks – Builds relationships within our own IT organization, our business stakeholders within our Company, as well as cross functionally to other organizations.
• Communicates Effectively – Strong importance on recognizing the audience and crafting the message accordingly.
• Global perspective – Ability to balance a single user requirement against a strong focus for a standardized model and be able to influence local users on a global approach.
• Ensures accountability – Ability to take responsibility to ensure success on any initiative and instill confidence in the team to drive to a positive outcome.

Current Employees apply HERE

Current Contingent Workers apply HERE