Senior MES Engineer

About Business Platforms:

Business Platforms specialises in Manufacturing Execution Systems (MES), Serialization, and Supply Chain Operations for our clients.

We provide consulting services globally to the Pharmaceutical Industry in

• Strategy Development and Execution
• Business Process Analysis and Design
• Change Management
• Validation
• Implementation and Support

We partner with our clients to provide expertise and industry best practice to create and realise business value.

Role : Senior MES Engineer

Duration : Full time position

Location : North Carolina

On site with client

Requirements of a Business Platforms Senior MES Engineer :

We are looking for an experienced Senior PAS-X Engineer to join our team supporting a major pharmaceutical manufacturing operation in Wilson, North Carolina .

This is an excellent opportunity for an experienced Werum PAS-X / Körber Pharma PAS-X consultant who has a strong background in MES implementation, EBR development and MBR design/configuration within a regulated pharmaceutical or life sciences environment.

The successful candidate will work closely with manufacturing, automation, IT and validation teams to design, develop and implement robust MES solutions supporting GMP manufacturing processes.

Key Responsibilities

• Design, configure, develop and support Werum/Körber PAS-X MES solutions.
• Lead and contribute to Electronic Batch Record (EBR) development and implementation.
• Develop, configure and maintain Master Batch Records (MBRs) within PAS-X.
• Translate manufacturing and business requirements into effective PAS-X solutions.
• Work closely with Manufacturing, Process Engineering, Automation, QA and IT teams.
• Configure PAS-X workflows, master data, recipes and manufacturing processes.
• Support MES integration with automation, DCS, PLC and other manufacturing systems.
• Troubleshoot and resolve PAS-X/MES issues in a production environment.
• Participate in system testing, including SIT, UAT and validation activities .
• Produce and review technical documentation in accordance with GMP and project standards.
• Support system releases, upgrades, enhancements and continuous improvement initiatives.
• Provide technical leadership and guidance to other MES/PAS-X engineers where required.
• Ensure solutions comply with applicable GxP, GMP, CSV and data integrity requirements .

Essential Experience

• 8–10+ years of professional experience in MES, with significant hands-on experience with Werum/Körber PAS-X .
• Strong hands-on experience with PAS-X MBR development and configuration .
• Proven experience developing and implementing Electronic Batch Records (EBRs) .
• Strong understanding of pharmaceutical manufacturing processes and GMP environments.
• Experience working on PAS-X implementation, deployment or enhancement projects.
• Experience working with cross-functional teams across Manufacturing, QA, Automation and IT.
• Strong understanding of MES integration with manufacturing/automation systems.
• Experience with GxP, GMP and CSV/validation environments.
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder-management skills.