Production Data & Process Support Specialist

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-driven innovation – at speed and scale

• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

• Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; colour; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.