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.