Production Data & Process Support Specialist

BioSpace; Pearl River (NY); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Sanofi's Pearl River site seeks a Production Data & Process Support Specialist to be the manufacturing-embedded expert for SAP S/4HANA, iShift, and related ERP/MES platforms. You will ensure data integrity, support daily operations, and drive quality governance across production.

You will design and deliver training, maintain SOPs, and collaborate with Master Data and IT to resolve data issues, enabling compliant manufacturing processes and continuous improvement.

Formación

• Bachelor's degree and 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

Responsabilidades

• Ensure SAP transactions are executed accurately, completely, and in full compliance with cGMP requirements and standards
• Provide real-time guidance and support to production personnel for SAP (S/4HANA) and iShift
• Monitor data quality in iShift and SAP; identify issues and escalate as needed
• Design and deliver training programs for SAP transactions and iShift data entry
• Develop and maintain training materials and job aids for consistent system usage
• Lead digital adoption and coach teams through system updates and changes
• Own data quality monitoring and govern data management in SAP and iShift
• Collaborate with Master Data teams on material master, orders, and batch records
• Identify data quality trends and document issues for stakeholders
• Coordinate with Supply Chain and Warehouse to ensure data flow and resolve interface issues
• Triage system issues with IT, Digital, or Master Data teams with clear impact analysis
• Participate in cross-functional meetings on iShift operations and governance
• Support continuous improvement of manufacturing data processes and SOPs
• Maintain up-to-date SOPs and work instructions for SAP and iShift
• Contribute to post-go-live stabilization and optimization with the Digital/iShift team

Conocimientos

SAP

iShift

Data quality

Training

cGMP

Data governance

ERP/MES

SOP development

Educación

Bachelor's degree

Herramientas

SAP S/4HANA

iShift

MES

ERP

Descripción del empleo

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 peoples 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 elevate 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 elevate 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 and 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. elevate 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