SAP Manufacturing Systems Specialist (Onsite)

Merck & Co.; Elmora (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Merck & Co. in Rahway, NJ, seeks a SAP Manufacturing Systems Specialist to own SAP master data across Material Masters, BOMs, Recipes, Production Versions, and Process Orders, ensuring accuracy and GMP compliance on the floor.

This onsite, second-shift role partners with Operations, Process Engineering, Quality, and Digital Tech to enable rapid, compliant manufacturing readiness for multi-modality drug product operations.

Qualifications

• Bachelor's degree in a relevant discipline is required.
• Minimum of 2 years' experience in a GMP manufacturing environment.
• Experience supporting Material Masters, BOMs, Recipes, Production Versions, and Process Orders.
• Strong data governance, document control, and regulatory compliance skills.

Responsibilities

• Create, maintain, and govern SAP Material Masters and related master data.
• Develop and maintain BOMs, Recipes, Production Versions, and process data.
• Support material staging, inventory transactions, and production execution activities.
• Collaborate with Operations, Process Engineering, Quality, and Digital Technology teams.
• Assist in change controls, validation, and SOP/documentation activities.

Skills

Collaboration

Analytical skills

Documentation

Communication skills

Attention to detail

PPE compliance

Education

Bachelor's degree in Engineering/Information Systems/Supply Chain/Manufacturing

Tools

SAP ECC/S/4HANA

PAS-X

Job description

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 skills to handle multiple priorities
• Ability to don all required gowning and personal protective equipment, such as a Powered Air Purifying Respirator.
• Proven track record of analytical skills, troubleshooting, and problem solving.
• Effective communication skills, both verbal and written.
• Strong attention to detail and documentation skills are required.
• Ability to communicate and work in partnership with other employees in a manufacturing environment.
• Ability to prepare Standard Operating Procedures and other GxP documents.
• High personal integrity, credibility, and energy.

Preferred Qualifications

• Experience with SAP ECC and/or SAP S/4HANA.
• Experience with PAS-X or other Manufacturing Execution Systems.
• Knowledge of material lifecycle management, change control, and master data governance.
• Understanding of production planning, warehouse management, and