We are working with a leading Pharma client of ours to seek a highly skilled MES MBR Designer with hands-on experience in PAS-X to join a growing team. In this role, you will be responsible for the design, configuration, and implementation of Master Batch Records (MBRs) to support digital manufacturing operations in a GxP-regulated environment.
As an MBR Designer, you will play a critical part in translating process knowledge into executable electronic batch records, enabling seamless execution and data integrity across manufacturing operations.
Key Responsibilities
Design, configure, and validate Master Batch Records (MBRs) in the PAS-X MES platform.
Translate process descriptions and manufacturing workflows into system logic aligned with GMP requirements.
Collaborate with cross-functional teams including QA, Manufacturing, Engineering, IT, and Business Process Owners.
Participate in system testing (IQ/OQ/PQ) and support validation documentation in alignment with CSV/GAMP5 principles.
Ensure MBRs support right-first-time execution, electronic data capture, and compliance with regulatory standards.
Troubleshoot and resolve issues related to MES functionality and batch execution.
Maintain and manage version-controlled MBR libraries and change control documentation.
Support MES rollouts, upgrades, and lifecycle management activities.
Required Qualifications
Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related discipline.
2+ years of experience in MES MBR design using PAS-X .
Proven experience in GxP-regulated manufacturing environments (pharmaceuticals, biotech, etc.).
Solid understanding of batch manufacturing processes and GMP requirements.
Familiarity with ISA-95/88 standards and MES integration with ERP, LIMS, and automation systems.
Strong documentation skills and attention to detail.
Excellent problem-solving and communication skills.
What’s in it for you?
Opportunity to work on cutting-edge MES projects in the life sciences sector.
Collaborative and innovative team environment.
Competitive rate and compensation.
Professional development and training opportunities.