- Type
- Full-time
- Department
- IT
- Seniority
- Manager
- Education
- Bachelor
- Source
- RecruiterFlow
Description
Réalta Technologies is looking for an experienced MES Technical Project Manager to support a major pharmaceutical manufacturing project in the US.
This is an exciting opportunity for someone with strong Werum PAS-X experience and a background in MES implementation, infrastructure, interfaces and electronic batch records.
You'll take ownership of end-to-end MES delivery, working closely with global and site teams to drive the implementation and testing of Global Master Batch Records (GMBRs) and Plant Master Batch Records (PMBRs), ensuring projects are delivered to schedule and the highest quality standards.
This is an exciting opportunity for someone with strong Werum PAS-X experience and a background in MES implementation, infrastructure, interfaces and electronic batch records.
You'll take ownership of end-to-end MES delivery, working closely with global and site teams to drive the implementation and testing of Global Master Batch Records (GMBRs) and Plant Master Batch Records (PMBRs), ensuring projects are delivered to schedule and the highest quality standards.
Job Responsibilities
- Lead the end-to-end implementation of MES solutions, ensuring delivery meets agreed project schedules, quality standards and site requirements.
- Coordinate with MES Infrastructure and Interface Platform Leads, Global MES Modelers and Site MES Modelers to deliver successful implementation of Global Master Batch Records (GMBRs) and Plant Master Batch Records (PMBRs).
- Develop, configure, implement and maintain MES batch records, ensuring alignment with global standards, site-specific requirements and manufacturing processes.
- Manage MES infrastructure and interface activities, including system configuration, integration, connectivity and data exchange between MES and associated manufacturing, automation and enterprise systems.
- Coordinate and execute MES testing activities, including functional testing, integration testing, end-to-end testing and User Acceptance Testing (UAT), ensuring systems perform as intended.
- Support the preparation and execution of validation documentation, test scripts, traceability matrices and implementation deliverables in accordance with applicable GMP and computer system validation requirements.
- Identify, manage and resolve technical issues, interface defects and implementation risks, coordinating with relevant technical and business stakeholders to ensure timely resolution.
- Oversee deployment and implementation activities, including environment readiness, configuration migration, release coordination, cutover and post-go-live support.
- Monitor project progress, manage dependencies and communicate delivery status, risks and issues to project stakeholders.
- Ensure MES solutions comply with pharmaceutical quality standards, data integrity requirements, site procedures and global manufacturing standards.
Job Requirements
- Bachelor's degree in Automation Engineering, Computer Science, Information Technology, Engineering or a related technical discipline, or equivalent relevant experience.
- Significant experience implementing, configuring and supporting Körber PAS-X MES within the pharmaceutical or biotechnology industry.
- Proven experience across the full MES implementation lifecycle, from requirements definition and design through configuration, testing, deployment and post-implementation support.
- Strong experience with MES infrastructure and system interfaces, including system connectivity, integration architecture, interface configuration, troubleshooting and data exchange between manufacturing systems.
- Demonstrated experience in batch record creation, configuration, implementation and testing, including Global Master Batch Records (GMBRs) and Plant Master Batch Records (PMBRs).
- Experience working collaboratively with global and site-level MES modelling teams, infrastructure platform leads, automation engineers and manufacturing stakeholders.
- Strong understanding of MES integration with automation and control systems, such as DCS, PLC/SCADA, and other manufacturing or enterprise applications.
- Practical experience developing and executing functional, integration, end-to-end and User Acceptance Testing (UAT) protocols, including defect management and resolution.
- Knowledge of GMP-regulated environments, pharmaceutical manufacturing processes, computer system validation (CSV) and data integrity requirements.
- Experience preparing technical documentation, validation deliverables, implementation plans and test documentation in a regulated environment.
- Proven ability to manage competing priorities, coordinate technical dependencies and deliver project milestones within agreed timelines and quality expectations.
- Strong communication, stakeholder management, problem-solving and organisational skills.
Skills
GMPPLCSCADA