About this role
<style type="text/css"> table.MiTabla { max-width: 1020px;!important </style> <table border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td><img src="https://staticweb.grifols.com/documents/675849/2554718/SSFF_02_CLAYTON.jpg/4f428334-9cb2-1679-ffa2-c56b3cd1097b?t=1636640425916" alt="" align="top/"></td> </tr> <tr> <td> <p style="text-align:justify">Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.</p> </td> </tr> <tr> <td><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></td> </tr> </tbody> </table><p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"> </p> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong><span style="color:windowtext">Location: Clayton NC</span></strong></span></p> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"> </p> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"> </p> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif;color:windowtext"><strong><span style="color:windowtext">Position Summary</span></strong></span></p> <div style="text-align:center;line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626" align="center"><hr align="center" size="2" width="100%"></div> <p style="margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif;color:windowtext"><span style="color:windowtext">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.</span></span></p> <p style="margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif;color:windowtext"><span style="color:windowtext"><br>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.</span></span></p> <p style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:Arial, sans-serif"> </p> <p style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:Arial, sans-serif"> </p> <p style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif"><strong><span style="color:windowtext">Key Responsibilities</span></strong></span></p> <div style="text-align:center;line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626" align="center"><hr align="center" size="2" width="100%"></div> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong><span style="color:windowtext">1. EBR/MES System Ownership & Governance</span></strong></span></p> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Serve as GT Manufacturing System Owner for EBR/MES Systems and associated digital systems, aligning with global governance expectations, testing standards, and change management.</span></li> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Own the site level configuration, functional administration, SOP’s, and lifecycle management of EBR/MES, and manufacturing IT systems.</span></li> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Coordinate and support recipe validation workflows, including SAP‑impacted and non‑SAP‑impacted changes, in alignment with site change management processes.</span></li> </ul> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong><span style="color:windowtext">2. Data Integrity Leadership</span></strong></span></p> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">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.</span></li> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Serve as GT Manufacturing Functional Owner of the HMI FTP server.</span></li> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Collaborate with Quality to assure inspection and audit readiness.</span></li> </ul> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong><span style="color:windowtext">3. Maximo GT Functional Management & Support</span></strong></span></p> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Act as the system owner and primary GT Manufacturing lead for the functional management of Maximo, the GT site CMMS system.</span></li> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Act as the liaison between Engineering/Maintenance and IT to ensure systems, reports, and processes support asset management, planning, and compliance. </span></li> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Develop KPIs, reports, SOPs, and training materials so Maintenance and Engineering can manage assets, spending, and performance effectively.</span></li> </ul> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong><span style="color:windowtext">4. Cross-System Integration & Digitalization</span></strong></span></p> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Lead site level functional integration initiatives between EBR, SAP, process automation systems, process historians, and other digital sources (e.g., logbooks, automation HMIs).</span></li> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Identify opportunities to automate data flows, reduce manual data entry, and modernize site operations.</span></li> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Drive Pharma 4.0–aligned digital solutions (e.g., digital logbooks, automated reporting, IoT sensors)</span></li> </ul> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong><span style="color:windowtext">5. Operational Support & Continuous Improvement – Aizon and Bioman</span></strong></span></p> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">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.</span></li> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Lead GT Manufacturing Digital Systems support for root cause analysis, CAPAs, preventive controls, and lifecycle improvements.</span></li> </ul> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong><span style="color:windowtext">6. Cross-Functional Leadership</span></strong></span></p> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Partner with Operations, Quality, IT, Production Maintenance and Engineering, Grifols Engineering, and Global Digital teams to harmonize data/standards and ensure effective system implementation.</span></li> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Represent the site in global councils/working groups related to EBR/MES, data integrity, and manufacturing digital systems.</span></li> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Influence site strategy for digital capabilities and future-state digital manufacturing systems.</span></li> </ul> <p style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"> </p> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"> </p> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong><span style="color:windowtext">Qualifications</span></strong></span></p> <div style="text-align:center;line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626" align="center"><hr align="center" size="2" width="100%"></div> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong><span style="color:windowtext">Required</span></strong></span></p> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.</span></li> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">8+ years of experience with MES/EBR systems, automation platforms (e.g., DeltaV, PLC’s), or manufacturing IT systems in a GMP environment.</span></li> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Strong experience with data integrity principles, computer system validation (CSV), and GxP regulations </span></li> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Demonstrated experience implementing or sustaining EBR/MES platforms.</span></li> </ul> <p style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"> </p> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong><span style="color:windowtext">Preferred</span></strong></span></p> <ul style="margin-bottom:0.0in;margin-top:0.0px" type="disc"> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Experience integrating MES/EBR with SAP, DCS, or data historians.</span></li> <li style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:14.0pt;font-family:arial, helvetica, sans-serif">Prior responsibility for site or functional system ownership or digital transformation in pharma/biotech.</span></li> </ul> <p style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:14.0pt;font-family:arial, helvetica, sans-serif"> </p> <p style="color:windowtext;line-height:15.0pt;margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:12.0pt;font-family:Arial, sans-serif"> </p> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"><strong><span style="color:windowtext">Occupational Demands</span></strong></span></p> <div style="text-align:center;line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626" align="center"><hr align="center" size="2" width="100%"></div> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"><span style="font-family:arial, helvetica, sans-serif;font-size:14.0pt"> 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.</span></p> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"> </p> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626"> </p> <p style="line-height:15.0pt;margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif;color:#262626">#LI-VJ1</p><p style="margin-bottom:11.0px"> </p> <p style="margin-bottom:11.0px"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Third Party Agency and Recruiter Notice:</span></span></p> <p style="margin-bottom:11.0px"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.</span></span></p> <p style="margin-bottom:11.0px"> </p> <p style="margin-bottom:11.0px"><strong><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">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.</span></span></strong></p> <p> </p> <p><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></p> <p><strong>Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton</strong> </p> <p> </p> <p><a href="https://www.grifols.com/en/what-we-do" target="_blank" rel="noopener">Learn more about Grifols</a></p> <p> </p>