Production Data & Process Support Specialist
Sanofi · Pearl River, New York, United States
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.
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.
About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.
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
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-dri