Bachelor's degree required; 3+ years in manufacturing operations or production support in a GMP-regulated industry.
Experience with SAP (manufacturing or supply chain modules) and/or MES/ERP systems in production environments.
Proven ability to train or coach others on system usage and process compliance.
Familiarity with digital manufacturing tools and data integrity principles (ALCOA+).
Strong analytical skills with a focus on problem-solving and decision-making.
Responsibilities
Ensure accurate execution of SAP transactions by manufacturing team members in compliance with cGMP requirements.
Act as the primary subject matter expert for SAP and iShift, providing real-time support to production personnel.
Monitor data accuracy in SAP and iShift, proactively addressing quality issues.
Design and deliver training programs on SAP transaction execution and iShift protocols.
Collaborate with Master Data teams to ensure governance-compliant data management.
Coordinate with Supply Chain and Warehouse teams for seamless data flow and process alignment.
Lead continuous improvement initiatives to enhance manufacturing data processes.
Benefits
Comprehensive employee benefit programs.
Opportunities for professional development and training.
Flexible work hours to support manufacturing operations.
Regular presence on the production floor for hands-on support.
Full Job Description
Job Title: Production Data & Process Support Specialist
Location: Pearl River, NY
About the Job
The Production Data & Process Support Specialist serves as the manufacturing-embedded expert for digital systems - primarily SAP (S/4HANA/iShift) and related ERP/MES platforms - ensuring that manufacturing personnel execute system transactions correctly, compliantly, and consistently in accordance with cGMP requirements. This role acts as the critical bridge between day-to-day manufacturing operations and the digital infrastructure that supports them, owning data quality and process integrity within the production environment.
Main Responsibilities
SAP & iShift Systems Execution
Ensure manufacturing team members execute SAP transactions accurately, completely, and in full 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 during daily operations
Monitor the accuracy and completeness of data entered into iShift and SAP; proactively identify data quality issues and take appropriate corrective action - either resolving directly within authorized scope or escalating through the proper channels (IT, Digital, or Master Data teams)
Training & Capability Development
Design and deliver training programs for manufacturing personnel on proper SAP transaction execution, iShift data entry protocols, and related digital workflows
Develop and maintain training materials, quick reference guides, and job aids to support consistent and compliant system usage across the manufacturing team
Serve as a change agent for digital adoption, coaching team members through system updates, process changes, and new iShift functionality rollouts
Data Governance & Quality
Own data quality monitoring within the manufacturing environment, establishing routines to review, validate, and correct production data in SAP and iShift
Collaborate closely with Master Data teams to ensure 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 to appropriate stakeholders
Cross-Functional Coordination
Coordinate proactively with Supply Chain and Warehouse teams to ensure seamless data flow, process alignment, and timely resolution of interface issues between manufacturing and downstream functions
Triage and escalate system issues to IT, Digital, or Master Data teams as appropriate, providing clear 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
Continuous Improvement & Documentation
Support and lead continuous improvement initiatives related to manufacturing data processes, identifying opportunities to streamline workflows, reduce errors, and improve data integrity
Maintain up-to-date standard operating procedures (SOPs) and work instructions for SAP and iShift system usage within the manufacturing environment
Contribute to post-go-live iShift stabilization and optimization efforts, serving as a key liaison between manufacturing operations and the Digital/iShift program team
About You
Bachelor's degree 3+ years of experience in manufacturing operations, production support, or manufacturing systems roles within any GMP regulated industry
Demonstrated experience working with SAP (manufacturing or supply chain modules) and/or MES/ERP systems in a production environment
Proven track record of training or coaching others on system usage or process compliance
Technical Skills
Working knowledge of SAP manufacturing modules (e.g., PP, MM, WM) and/or SAP S/4HANA
Familiarity with digital manufacturing tools
Ability to identify, analyze, and resolve data discrepancies within ERP/MES systems
Regulatory & Compliance
Understanding of current Good Manufacturing Practice (cGMP) requirements and their application to data entry, batch records, and electronic systems in a pharmaceutical manufacturing environment
Awareness of data integrity principles (ALCOA+) as they apply to electronic systems
Interpersonal & Professional Skills
Strong analytical and problem-solving skills with the ability to make sound judgment calls on when to resolve vs. escalate issues
Excellent written and verbal communication skills; ability to translate technical system requirements into clear, actionable guidance for manufacturing personnel
Demonstrated ability to influence without authority and drive adoption of new processes or systems
PREFERRED QUALIFICATIONS
Experience with SAP S/4HANA or direct involvement in an iShift implementation or go-live support
Prior experience in pharmaceutical, biopharmaceutical, or vaccine manufacturing environments
Familiarity with master data governance processes, including material master creation/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
CORE COMPETENCIES / PROFICIENCY
Technical
Production Data Management / Advanced
Digital Technology / Advanced
Manufacturing Documentation / Intermediate
Safety Culture / Intermediate
Functional
Process Control / Experienced
Process Optimization / Experienced
Data Processing / Advanced
Process Improvements / Advanced
Transversal
Collaborative Communications / Experienced
Cross-Functional Teamwork / Mastered
Other
GMP Compliance / Advanced
PHYSICAL REQUIREMENTS & WORK ENVIRONMENT
Based at Sanofi's Pearl River manufacturing site
Regular presence on the production floor is required to provide in-person support to manufacturing personnel during operational hours
Office-based work for documentation, training development, and cross-functional coordination
Standard business hours with flexibility to support manufacturing operations as needed, which may include occasional off-shift or weekend coverage during system go-lives, critical issue resolution, or training events
Must comply with all site safety, gowning, and access requirements applicable to manufacturing areas
The salary range for this position is: $90.000,00 - $130.000,00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
About Sanofi
Sanofi is a global pharmaceutical company that specializes in the research, development, and manufacturing of prescription drugs and vaccines. The company operates in over 170 countries and has a diverse portfolio of products that includes treatments for diabetes, cancer, cardiovascular disease, and rare diseases. Sanofi is committed to improving global health and has a strong focus on innovation and sustainability. The company has received numerous awards for its research and development efforts and is recognized as a leader in the pharmaceutical industry.
