Computer System Validation Csv Jobs in Cary, NC (NOW HIRING)

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 (EBR/MES), Maximo GT Functional Management, Data Integrity FTP server, Aizon, Bioman, and related GMP data systems at GT. This role ensures regulatory‑compliant data integrity across digital manufacturing systems, supports the operationalization of EBR, 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 EBR/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 EBR/MES teams for build, delivery, and validation of these systems.

• Serve as GT Manufacturing System Owner for EBR/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 EBR/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 EBR, 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 EBR/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 EBR/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/EBR 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 EBR/MES platforms.

• Experience integrating MES/EBR 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 with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.