USA - Manufacturing Specialist

• Manufacturing Technical MES System Specialist
• 9-month contract with the possibility of extending or converting to permanent.
• Responsible for maintaining and updating current established electronic batch records in the Client-X Werum MES (manufacturing execution system) for the Cell & Gene site in Morris Plains.
• Personnel must be skilled in Master Batch Record creation and maintenance for MES Production system.
• Create new electronic batch records as required to support production processing.
• Provide oversight and execution for the manufacturing execution system (MES) which will automate much of the record keeping, information flow and documentation for Morris Plains Cell Processing Operations. MES is interfaced with SAP System to issue Materials to MBRs that are acceptable & released.
• Provide paperless Production recipes within the MES Client-X system.
• Maintain, create and support PU process improvement changes.
• Provide MES support for Production on processing troubleshooting issues
• All maintenance activities for Master Batch Records, following all appropriate procedural documentation.
• Implementation and maintenance of LIMS interactions and interactions for deviation generation during the process.
• Provide timely and error free documentation.
• Properly control the release of proprietary documentation.
• Demonstrate technical knowledge in MES systems.
• Reduce the number of Master Batch Record revisions due to record flow or design
• Responsible for ensuring compliance with Federal, State and local regulations and adherence to all company policies and procedures relating to GMPs, Health, Safety & Environmental Protection.
• Work with Manufacturing Team to implement change improvements
• Maintain Material Master within the SAP System
• Backup to SAP Bill of Material Maintenance.
• Coordinate with IT Group MES upgrades and or changes to the system for Compliance, Training & MBR changes.
• Coordinate with IT group User ID controls.

• Education: Bachelor or similar degree
• 3+ years experience in a regulated cGMP environment or other regulatory related industry preferred Pharma Industry
• 3+ years Manufacturing Execution Systems required
• Strong aseptic manufacturing knowledge background preferred.
• This professional must be proactive, responsive, and able to work independently with all levels of the organization.
• Must possess full fluency in MS Office (Word, Outlook, PowerPoint, MES, ERP, database management) and be an excellent communicator.
• Must be service-minded, flexible, and possess strong interpersonal skills.
• Capability to handle multiple conflicting tasks in a fast-paced environment is a must.
• Very high attention to detail is critical, including strong writing and proofreading skills.
• Skilled in Master Batch Record Creation and Maintenance for both Production using MES (Manufacturing Execution Systems).

Last updated on Sep 27, 2023