Manufacturing Digital Manager

Location:

Clayton NC Position Summary

The Grifols Therapeutics Manager of Manufacturing Digital Systems, is the GT site functional leader responsible for site-level functional ownership, governance, integrity, and optimization of digital manufacturing systems, including Electronic Batch Records (E /MES), Maximo GT Functional Management, Data Integrity FTP server, Aizon, Bioman, and related GMP data systems s role ensures regulatory‑compliant data integrity across digital manufacturing systems, supports the operationalization of E , and coordinates cross‑system integration with platforms such as SAP, process historians, and process automation systems for manufacturing.

The role serves as the GT Manufacturing Support E /MES Systems owner as defined in the global RACI, with accountability for site functional direction governance. This role is a critical partner to Quality, Operations, Global IT, and Global Biopharma E /MES teams for build, delivery, and validation of these systems.

• Serve as GT Manufacturing System Owner for E /MES Systems and associated digital systems, aligning with global governance expectations, testing standards, and change management.
• Own the site level configuration, functional administration, SOP’s, and lifecycle management of E /MES, and manufacturing IT systems.
• Coordinate and support recipe validation workflows, including SAP‑impacted and non‑SAP‑impacted changes, in alignment with site change management processes.

• Collaborate with site Quality as the GT Manufacturing Digital Systems representative to the Data Integrity Program for digital manufacturing control systems, ensuring alignment with regulatory and global corporate standards.
• Serve as GT Manufacturing Functional Owner of the HMI FTP server.
• Collaborate with Quality to assure inspection and audit readiness.
• Act as the system owner and primary GT Manufacturing lead for the functional management of Maximo, the GT site CMMS system.
• Act as the liaison between Engineering/Maintenance and IT to ensure systems, reports, and processes support asset management, planning, and compliance.
• Develop KPIs, reports, SOPs, and training materials so Maintenance and Engineering can manage assets, spending, and performance effectively.
• Lead site level functional integration initiatives between E , SAP, process automation systems, process historians, and other digital sources (e.g., logbooks, automation HMIs).
• Identify opportunities to automate data flows, reduce manual data entry, and modernize site operations.
• Drive Pharma 4.0–aligned digital solutions (e.g., digital logbooks, automated reporting, IoT sensors)

• Oversee site coordination of system incident management and interface with IT Infrastructure, Global E /MES, automation teams, Aizon data teams, and Bioman production data teams.
• Lead GT Manufacturing Digital Systems support for root cause analysis, CAPAs, preventive controls, and lifecycle improvements.

• Partner with Operations, Quality, IT, Production Maintenance and Engineering, Grifols Engineering, and Global Digital teams to harmonize data/standards and ensure effective system implementation.
• Represent the site in global councils/working groups related to E /MES, data integrity, and manufacturing digital systems.
• Influence site strategy for digital capabilities and future‑state digital manufacturing systems.

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
• 8+ years of experience with MES/E  systems, automation platforms (e.g., DeltaV, PLC’s), or manufacturing IT systems in a GMP environment.
• Strong experience with data integrity principles, computer system validation (CSV), and GxP regulations
• Demonstrated experience implementing or sustaining E /MES platforms.

• Experience integrating MES/E  with SAP, DCS, or data historians.
• Prior responsibility for site or functional system ownership or digital transformation in pharma/biotech.

Work is performed in an office environment…