Lead the design, configuration, and optimization of PAS-X process models, eMBR templates, operator displays, and associated configurations to deliver robust, user-centric manufacturing solutions.
Translate manufacturing process requirements into PAS-X process models, workflows, step templates, variable structures, and scripted actions that guide operators and automate batch execution.
Own eMBR structure and design: controlled documents, dynamic forms, signatures, conditional routing, and data capture to meet 21 CFR Part 11 and GxP requirements (in collaboration with Validation and QA).
Work closely with Manufacturing SMEs, Process Engineers, QA/Validation, and Integration teams to ensure accurate representation of processes, clear electronic instructions, and reliable data capture.
Provide subject matter expertise on PAS-X configuration best practices, naming conventions, library management, and process model governance to ensure consistency across sites.
Lead configuration change activities, including impact analysis, design artifacts, configuration changes, unit/integration test scripts, and support validation activities.
Ensure all deliverables conform to applicable compliance standards (CSV, GxP, Records Management, SOX) and site/regional policies.
Key Responsibilities
Capture detailed process requirements from manufacturing and translate them into PAS-X process models and eMBR designs.
Configure PAS-X process modules: steps, activities, transitions, parameters, equipment/resource assignments, and material flows.
Build and configure eMBR templates and dynamic forms, including electronic signoffs, nested checklists, conditional fields, and audit trail considerations.
Design operator UIs and screen flows to optimize clarity and reduce operator cognitive load, implementing visual cues and structured data entry where appropriate.
Develop and maintain reusable PAS-X configuration libraries, templates, and pattern models to accelerate deployments and enforce standardization.
Collaborate on integration requirements for LIMS, SCADA, ERP, and instrumentation to ensure correct data mapping and handoffs for eMBR population.
Create configuration documentation, process model diagrams, test cases, and runbooks for handover to Validation and Support teams.
Lead design reviews, workshops, and training sessions for site super users and operators.
Support continuous improvement initiatives driven by site performance metrics and operator feedback.
Required Qualifications
5+ years' experience supporting PAS-X MES with a primary focus on process modeling, eMBR design, and front-end configuration.
Demonstrated hands-on experience building PAS-X process models, step templates, forms, and operator screens.
Strong understanding of electronic batch record concepts, electronic signatures, audit trails, and how to design eMBRs to meet 21 CFR Part 11 and GxP expectations.
Proven ability to translate manufacturing SOPs and engineering processes into executable MES workflows and UI designs.
Experience working directly with Manufacturing SMEs, QA/Validation, and operators to design usable and compliant eMBRs.
Strong troubleshooting skills for PAS-X configurations and the ability to analyze and resolve process model issues affecting execution.
Excellent written and verbal communication skills with experience leading workshops and delivering operator training materials.
Bachelor's degree in Engineering, Life Sciences, Computer Science, or equivalent experience.
Experience in a matrixed, global environment and the ability to manage relationships with internal and third-party teams.
Preferred Qualifications
PAS-X certification or formal training in PAS-X process modeling/configuration.
Prior experience with eBR/eMBR projects in a regulated biotech or pharmaceutical manufacturing environment.
Familiarity with integration patterns to LIMS, PLC/SCADA, and ERP for automated data collection into eMBRs.
Experience creating design artifacts that support Computer System Validation (CSV) and testable requirements.
Experience mentoring or leading small configuration teams and managing vendor resources focused on MES configuration.
