The MES Specialists will be responsible for the design, administration, and ongoing optimization of PAS-X systems in manufacturing environments. The ideal candidate will have extensive experience with the PAS-X platform, a deep understanding of GMP processes, and a track record of successful system integration and project delivery.
Candidates should have experience in at least one of the following areas:
MES Design and Development
Analyze business and operational requirements to configure and design PAS-X solutions.
Develop workflows, master batch records, and system specifications tailored to client needs.
Ensure seamless integration of PAS-X with other systems, such as ERP, SCADA, and LIMS.
System Ownership
Act as the System Owner for PAS-X implementations, ensuring operational excellence and compliance.
Monitor system performance, resolve issues, and implement enhancements.
Maintain comprehensive documentation, including system configurations and validation protocols.
System Administration
Oversee user management, role-based permissions, and data security within PAS-X.
Coordinate software updates, patches, and system upgrades.
Develop and implement protocols for system backups and disaster recovery.
Project Management
Lead PAS-X implementation and upgrade projects, ensuring adherence to scope, timeline, and budget.
Collaborate with cross-functional teams, including IT, automation, and production.
Manage vendor relationships and ensure the delivery of high-quality solutions.
Conduct risk assessments and establish mitigation plans.
Training and Support
Provide end-user training on PAS-X functionalities and workflows.
Offer ongoing support and troubleshooting to ensure smooth system operation.
Drive adoption of system best practices across the organization.
Qualifications & Skills
Bachelor's degree in Engineering, Computer Science, or a related field.
3+ years of hands-on experience with PAS-X MES platform.
Proven track record of designing and managing MES solutions in GMP-regulated environments.
Experience integrating PAS-X with ERP, SCADA, and LIMS systems.
Proficient in PAS-X configuration, including master batch record development and system workflows.
Strong understanding of GMP, FDA, and ISO regulations.
Excellent problem-solving and troubleshooting skills.
Exceptional communication and project management abilities.
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