Organon
Senior Specialist – Serialization Operations Americas/Spécialiste principal(e) – Opérations de Sérialisation, Amériques

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The Position
Reporting into the Serialization Lead in the Global Serialization Centre of Excellence team, the successful candidate will act as a key point of contact and SME for serialization support and issue escalation within the Americas region.
Responsibilities
- Oversee inbound logistics and serialization data flow from manufacturing sites to Organon’s third-party logistics (3PL) provider, ensuring EPCIS compliance ahead of product receipt
- Gather and document serialization requirements for new markets
- Execute and/or participate in project teams in design, build, and deployment activities
- Contribute to project impact assessment and scoping
- Act as a key contributor to new product launch initiatives by providing serialization expertise and supporting operational execution across impacted markets
- Liaison for Organon’s 3PL provider, reviewing and monitoring customer exceptions to ensure timely resolution and service compliance
- Collaborate with 3PL partner to maintain operational compliance, drive process improvements, and ensure adherence to customer and company requirements
- Utilize Verification Router Service (VRS) to assess and validate suspect product, partnering with Quality to investigate issues, determine root cause, and support disposition decisions to ensure compliance and product integrity
- Contribute as a key team member in onboarding Contract Manufacturing Organizations (CMOs), supporting cross-functional coordination to ensure alignment with quality, compliance, and operational requirements
- Process xml messages via the Advanced Track & Trace Cockpit
- Utilized the Integration Control Hub (ICH) to monitor and reprocess message flows, ensuring accurate data exchange and timely resolution of errors
- Create shipping and receiving events
- Write standard operating procedures and work-step instructions
- Collaborate with Business Technology (BT) to support serialization activities, ensuring system accuracy, data integrity, and compliance with traceability requirements
- Serve as a resource for team members, providing guidance on processes and supporting questions related to daily activities
- Actively search for process efficiencies in the team
- Act as backup support for team members during absences, covering Master Data, reporting, and daily business activities to ensure continuity and accuracy
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Required Education, Experience & Skills
- Minimum of 4 years of relevant work experience i.e. Supply Chain Management, Plant Operations, Distribution, Logistics, Regulatory etc.
- Minimum of 2 years experience working with Serialization processes and data requirements
- Strong knowledge of Pharmaceutical Serialization, GS1 Standards and related technologies (EPCIS)
- Knowledge of Pharmaceutical Track and Trace regulatory reporting requirements
- Knowledge in GS1 standards (GTIN, SGTIN, GLN, SGLN, SSCC, GCP)
- Business process knowledge on pharmaceutical products packaging, aggregation, barcode printing and verification
- Good experience of working with SAP ATTP integration with SAP ECC, packaging line management solution and SAP ICH
- Demonstrated ability to align, lead and drive change activities across global and/or cross-functional teams towards a common goal. A strong appreciation that the best results come from the combined efforts of diverse teams and shared perspectives.
- Strong oral and written communication skills in English with a proven ability to organize business process and complex information in a concise and compelling manner.
- Lean/continuous improvement mindset.
- The role will be based in the US time zone, EST.


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Preferred Education, Experience & Skills
- B.S. in Business, Supply Chain, Engineering or other technical degree.
- Understanding of GxP environments
- Demonstrated project management experience.
- Secondary Language(s)
Who We Are
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.
Employee Status
- Regular
- Relocation: No relocation
- VISA Sponsorship:
- Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
- Flexible Work Arrangements:
- Shift:
- Valid Driving License:
- Hazardous Material(s):
- Number of Openings: 1
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