SAP Manufacturing Systems Specialist (Onsite)

About this role

Job Description

The FLEx Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and GMP clinical manufacturing plant in Rahway, New Jersey. The FLEx organization has a mission to enable development of our Company’s pipeline products with speed, agility, and rigor. This mission will be accomplished by: 1) Enabling robust formulation and process development with flexible physical and digital infrastructure; 2) Delivering compliant, high quality clinical supplies; 3) Developing talent with a new operating model and promoting a growth mindset.

The FLEx organization is seeking a highly motivated individual to serve the role of SAP Manufacturing Systems Specialist. The successful candidate will act as subject matter expert for SAP manufacturing master data and production execution processes, ensuring accurate and compliant configuration of Material Masters, BOMs, Recipes, Production Versions, and Process Orders in support of GMP manufacturing operations, while also supporting activities such as material staging, inventory transactions, and manufacturing operations. The position partners with Operations, Process Engineering, Quality, Master Data Management, and Digital Technology organizations to ensure manufacturing data accuracy, regulatory compliance, and operational readiness for production activities. This is an onsite based role on second shift in Rahway, New Jersey and reports to the Systems Process Lead Director at the FLEx Center in the Pharmaceutical Operations and Clinical Supply organization.

Responsibilities of the SAP Manufacturing Systems Specialist include but are not limited to:

SAP Master Data Management • Create, maintain, and govern SAP Material Masters throughout the material lifecycle. • Develop and maintain Bills of Material (BOMs), Recipes, Production Versions, and related manufacturing master data. • Support implementation of engineering changes and change controls impacting manufacturing master data. • Ensure master data accuracy, consistency, and compliance with established governance procedures. • Coordinate with global and local master data organizations to facilitate material creation, extension, and updates. • Participate in master data audits, investigations, and continuous improvement initiatives.

Manufacturing Execution Support • Support creation, release, monitoring, and troubleshooting of Process Orders. • Provide SAP support for material dispensing, goods movements, inventory transactions, and production execution activities. • Partner with manufacturing operations to resolve SAP issues impacting batch execution. • Support manufacturing readiness activities for new products, process changes, and technology transfers. • Monitor production transaction accuracy and resolve execution discrepancies

Business Process Improvement • Evaluate system usage and implement business process enhancements to improve efficiency, compliance, and user experience. • Develop standardized procedures and training materials for SAP manufacturing processes. • Participate in testing, validation, and deployment of system enhancements and upgrades.

Change Control and System Lifecycle Management • Author, execute, and close change controls associated with SAP manufacturing processes, system enhancements, master data changes, and manufacturing system implementations. • Assess impact of proposed changes on manufacturing processes, data integrity, electronic records, and GMP compliance. • Develop implementation plans, risk assessments, testing strategies, and supporting documentation required for change control execution.

SOP and Documentation Management • Author, revise, and maintain Standard Operating Procedures (SOPs), work instructions, training materials, and system documentation related to SAP manufacturing processes. • Ensure procedures remain aligned with current system functionality, regulatory requirements, and business processes. • Assess procedural impacts resulting from system enhancements, process changes, and implementation activities. • Support training development and delivery for operations personnel, process engineers, and other system users.

Hardware and Shop Floor Systems Support • Provide operational support and troubleshooting for manufacturing hardware utilized in conjunction with SAP and connected manufacturing systems. • Support configuration, maintenance, and lifecycle management of: • Barcode scanners • Label printers • Manufacturing printers • Tablets and mobile devices • Fixed and mobile workstations • Shop floor peripheral devices

• Support deployment, replacement, qualification, and maintenance activities for manufacturing system hardware.

MES and System Integration • Collaborate with MES teams to ensure alignment between SAP master data and electronic batch records. • Support integration activities between SAP, PAS-X, and other manufacturing systems. • Investigate and resolve data integration issues affecting manufacturing execution.

Compliance and Quality

• Ensure compliance with GMP, regulatory, and data integrity requirements. • Support deviation investigations, CAPAs, audits, and inspections related to SAP manufacturing processes. • Participate in validation and change management activities. • Maintain compliance with site and corporate procedures governing SAP master data and manufacturing operations.

Required Qualifications • Bachelor's degree in Engineering, Information Systems, Supply Chain, Manufacturing, or related discipline. • Strong understanding of pharmaceutical manufacturing operations and GMP requirements. • Minimum of 2 years of experience in a GMP manufacturing environment  • Experience supporting: • Material Masters • Bills of Material (BOM) • Recipes • Production Versions • Process Orders • Inventory and material movement transactions

• Ability to work collaboratively as part of a team across various functions in a challenging and changing global environment. • Excellent organizational

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