Manufacturing Systems Specialist Jobs (NOW HIRING)

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 shop floor execution processes.
• Familiarity with digital manufacturing initiatives and system integrations.

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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