Specialist MBR Author

Job Description

The Manufacturing Execution System (MES) Specialist acts as a subject matter expert. The MES Specialist’s primary responsibility is to ensure that the deployment of the Werum/Korber PAS-X electronic Master Batch Records are successfully and compliantly designed, developed, deployed, and supported to maximize business benefits and are in line with site business process and technical standards. The Specialist is responsible for following standard processes and procedures in performing their duties. These include cGMP regulations, SOPs and global business processes. The MES Specialist is responsible for activities that include the following:

• Identifies and implements continuous process improvement opportunities.

• Sustain electronic Master Batch Records, bringing together knowledge of manufacturing processes, and standard Werum/Korber generic master batch record (GMBR) configuration. 

Executes the appropriate change control and electronic Master Batch Record life-cycle actions and processes to assure the MES system is in a state of control and compliance. Collaborates and assists with troubleshooting to efficiently resolve manufacturing problems, providing MES support to ongoing Electronic Batch Record (EBR) operations. Knowledge of Quality Systems and Regulatory Standards to provide assurance and foster quality decisions with project teams and their site Quality unit.

Education Minimum Requirement:

• Bachelor’s Degree and 4+ years of MES support experience or 6+ years of relevant MES experience

Required Experience and Skills:

•  Direct experience with MES (PAS-X) with strong experience in MBR, GMBR design

• Proven track record of analytical skills, problem solving and attention to detail.

• High personal integrity, credibility, and energy

 • Excellent communication and influencing skills.

• Strong written and verbal communication skills Minimum three (3) years of experience in a production regulated industry.   

• Strong understanding of manufacturing principles/processes (preferably Biologics) and ability to translate manufacturing requirements into Automation/Digital Solution

Preferred Experience and Skills:

• Knowledge of SAP
• Knowledge of L2 Systems (Historian, SCADA, DCS)

Primary Skills: Pas-X - 3.3 or 3.18, MBR Design, MBR record

Secondary Skill: SAP, Knowledge of L2 Systems (Historian, SCADA, DCS)

Required Skills:

Accountability, Automation, Biopharmaceuticals, Business Processes, Change Controls, Communication, Continuous Process Improvement, Group Problem Solving, Machine Troubleshooting, Manufacturing, Manufacturing Execution Systems (MES), Manufacturing Processes, Master Batch Records, MES Integration, Oral Communications, Perform Testing, Problem Solving, Quality Assurance (QA) Standards, Quality Management, Regulatory Compliance, SAP MES, Software Development Life Cycle (SDLC), Technical Writing, Troubleshooting, Werum's PAS-X MES

Preferred Skills:

SAP Integrations

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/13/2026

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