Production Data & Process Support Specialist

Sanofi•Pearl River, NY
•$90,000 - $130,000•Onsite

About The Position

The Production Data & Process Support Specialist is embedded in manufacturing and serves as the subject matter expert for digital systems, primarily SAP (S/4HANA/iShift) and related ERP/MES platforms. The role helps manufacturing personnel execute system transactions accurately, consistently, and in compliance with cGMP requirements and Sanofi's iShift core model standards. It bridges daily manufacturing operations and the digital infrastructure supporting them, with responsibility for data quality and process integrity in the production environment. Based at Sanofi's Pearl River manufacturing site, the position requires regular presence on the production floor to support manufacturing personnel in person during operational hours, as well as office-based work for documentation, training development, and cross-functional coordination. The schedule is standard business hours with flexibility to support operations as needed, including occasional off-shift or weekend coverage for system go-lives, critical issue resolution, or training events. The role must comply with site safety, gowning, and access requirements for manufacturing areas.

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.
  • A track record of 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 within 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 applied 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 actionable guidance for manufacturing personnel.
  • Ability to influence without authority and drive adoption of new processes or systems.
  • Ability to comply with applicable site safety, gowning, and access requirements.

Nice To Haves

  • Experience with SAP S/4HANA or direct involvement in an iShift implementation or go-live support.
  • Experience in pharmaceutical, biopharmaceutical, or vaccine manufacturing.
  • Familiarity with master data governance processes, including material master creation/change request workflows.
  • Experience supporting 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 primary manufacturing-embedded subject matter expert for SAP (S/4HANA) and iShift, providing real-time guidance and support to production personnel.
  • Monitor data entered into iShift and SAP, identify data quality issues, and resolve them within authorized scope or escalate them through appropriate channels.
  • Design and deliver training on SAP transactions, iShift data entry protocols, and related digital workflows.
  • Develop and maintain training materials, quick reference guides, and job aids for consistent and compliant system usage.
  • Coach team members through system updates, process changes, and new iShift functionality rollouts to support digital adoption.
  • Establish routines to review, validate, and correct production data in SAP and iShift.
  • Collaborate with Master Data teams on accurate, timely, and governance-compliant management of 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, documenting 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 for manufacturing data processes to streamline workflows, reduce errors, and improve data integrity.
  • Maintain current SOPs and work instructions for SAP and iShift usage in the manufacturing environment.
  • Contribute to post-go-live iShift stabilization and optimization, serving as a liaison between manufacturing operations and the Digital/iShift program team.

Benefits

  • Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
  • At least 14 weeks of gender-neutral parental leave.
  • Company employee benefit programs; eligibility may apply.
  • Rewards package recognizing employee contributions.
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