support of enterprise serialization systems across Levels 3–5, with a primary focus on SAP OER, SAP ATTP,
SAP eWM, EPCIS integration, and external data exchange. This role serves as a subject matter expert for
serialization data flows between internal ERP/WMS systems, Contract Manufacturing Organizations (CMOs),
Product Partners, 3PLs, and downstream trading partners. The Senior Engineer leads onboarding activities for
CMOs and Product Partnering, manages TraceLink/ATTP/OER data connections, ensures compliant EPCIS
messaging, and resolves data exceptions related to commissioning, aggregation, shipment, and verification
events.
The position provides technical leadership in virtualization, server/system deployment, SQL database analysis,
and serialization interface troubleshooting. Working cross-functionally with IT, Supply Chain, Quality,
Packaging Engineering, and external partners, the role ensures compliant and timely data exchange to support
commercial distribution under DSCSA and global serialization regulations. Responsibilities also include
supporting system upgrades, patching, validation (CSV), data mapping, and integration testing aligned with
cGMP, ALCOA+, 21 CFR Part 11, and GAMP5 requirements.
Salary Range: $110,000-120,000
Position is eligible to participate in an annual bonus plan with a target of 6% of the base salary.
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.Responsibilities
1) Owns serialization system architecture at Levels 3–5, including SAP OER, SAP ATTP, SAP eWM, and related SAP modules.
2) Configures and maintains serialization data exchange interfaces between internal systems, CMOs, 3PLs, product partners, and regulatory agencies.
3) Supports onboarding of CMOs and Product Partnering through EPCIS mapping, credentialing, and interface testing.
4) Administers TraceLink/Nexus/Partner portals for serialization data exchange and event reporting.
5) Troubleshoots data exceptions for commissioning, aggregation, shipment, and verification events.
6) Performs SQL data analysis and query development to support issue resolution, data validation, and reporting.
7) Manages system deployment via virtualized environments (VMware, Hyper-V, cloud environments, etc.).
8) Executes upgrades, patches, and CSV-related validation testing for serialization systems.
9) Ensures compliance with DSCSA, EU-FMD, GS1 EPCIS standards, and other global serialization requirements.
10) Coordinates with SAP Basis, Infrastructure, Security, and QA/CSV teams to support system lifecycle.
11) Resolves integration issues across ERP, MES, WMS, and partner systems.
12) Supports data migration and master data alignment (GTIN, GLN, TIN, SN ranges, aggregation rules).
13) Participates in audits, inspections, and regulatory queries related to serialization data.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.
Additional InformationWe offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Top Skills
What We Do
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients.
Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face.
Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.
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