Production Data & Process Support Specialist

Sanofi•Pearl River, NY
•Onsite

About The Position

The Production Data & Process Support Specialist is embedded in manufacturing and supports digital systems—primarily SAP (S/4HANA/iShift) and related ERP/MES platforms. The role ensures manufacturing personnel execute system transactions accurately, consistently, and in compliance with cGMP requirements and Sanofi’s iShift core model standards. It serves as a bridge between daily manufacturing operations and the digital infrastructure supporting them, with responsibility for production-environment data quality and process integrity. The specialist provides real-time SAP and iShift guidance to production personnel, monitors and addresses data-quality issues, and develops training and job aids. The role collaborates with Master Data, Supply Chain, Warehouse, IT, Digital, and other stakeholders to resolve issues and maintain data governance. It also supports continuous improvement, documentation, and post-go-live iShift stabilization and optimization. The position is based at Sanofi’s Pearl River manufacturing site. It requires regular production-floor presence as well as office-based documentation, training development, and coordination. Standard business hours apply, with flexibility for occasional off-shift or weekend coverage during go-lives, critical issue resolution, or training events. Site safety, gowning, and access requirements must be followed.

Requirements

  • Bachelor’s degree.
  • At least 3 years of experience in manufacturing operations, production support, or manufacturing systems roles within a GMP-regulated industry.
  • Demonstrated experience with SAP manufacturing or supply-chain modules and/or MES/ERP systems in a production environment.
  • Proven experience training or coaching others on system usage or process compliance.
  • Working knowledge of SAP manufacturing modules such as PP, MM, or WM, and/or SAP S/4HANA.
  • Familiarity with digital manufacturing tools.
  • Ability to identify, analyze, and resolve data discrepancies in ERP/MES systems.
  • Understanding of cGMP requirements and their application to data entry, batch records, and electronic systems in pharmaceutical manufacturing.
  • Awareness of ALCOA+ data integrity principles as they apply to electronic systems.
  • Strong analytical and problem-solving skills, including sound judgment about when to resolve or escalate issues.
  • Excellent written and verbal communication skills, including the ability to translate technical system requirements into clear guidance for manufacturing personnel.
  • Ability to influence without authority and drive adoption of new processes or systems.
  • Ability to support manufacturing operations as needed, including occasional off-shift or weekend coverage during system go-lives, critical issue resolution, or training events.
  • Must comply with site safety, gowning, and access requirements applicable to manufacturing areas.

Nice To Haves

  • Experience with SAP S/4HANA or direct involvement in an iShift implementation or go-live support.
  • Prior experience in pharmaceutical, biopharmaceutical, or vaccine manufacturing.
  • Familiarity with master data governance, including material master creation and change-request workflows.
  • Experience with data integrity programs or quality management systems in a GMP-regulated environment.
  • Lean, Six Sigma, or other continuous improvement training or certification.
  • Experience supporting cross-functional teams spanning Supply Chain, Warehouse, and Manufacturing Operations.

Responsibilities

  • Ensure manufacturing team members execute SAP transactions accurately, completely, and in compliance with cGMP requirements and Sanofi’s iShift core model standards.
  • Serve as the manufacturing-embedded subject matter expert for SAP (S/4HANA) and iShift, providing real-time guidance and support during daily operations.
  • Monitor iShift and SAP data for accuracy and completeness; identify and correct issues within authorized scope or escalate them through appropriate channels.
  • Design and deliver training on SAP transaction execution, iShift data-entry protocols, and related digital workflows.
  • Develop and maintain training materials, quick reference guides, and job aids.
  • Coach team members through system updates, process changes, and new iShift functionality rollouts.
  • Establish routines to review, validate, and correct production data in SAP and iShift.
  • Collaborate with Master Data teams on accurate, timely, and governance-compliant data management, including material master data, production orders, and batch records.
  • Identify recurring data-quality trends and escalate systemic issues with supporting documentation.
  • Coordinate with Supply Chain and Warehouse teams to support data flow, process alignment, and resolution of interface issues.
  • Triage and escalate system issues to IT, Digital, or Master Data teams with documentation of the issue, business impact, and recommended resolution path.
  • Participate in cross-functional meetings and working groups related to iShift operations, data governance, and manufacturing process alignment.
  • Support and lead continuous improvement initiatives to streamline manufacturing data workflows, reduce errors, and improve data integrity.
  • Maintain standard operating procedures and work instructions for SAP and iShift usage in the manufacturing environment.
  • Contribute to post-go-live iShift stabilization and optimization as a liaison between manufacturing operations and the Digital/iShift program team.

Benefits

  • Health and wellbeing benefits, including high-quality healthcare and prevention and wellness programs.
  • At least 14 weeks of gender-neutral parental leave.
  • Employees may be eligible to participate in company employee benefit programs.
  • A rewards package recognizing employee contributions.
  • Opportunities for career growth through promotion or lateral moves, at home or internationally.
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