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Inteldot

MES Specialist (PAS-X)

Inteldot, Raleigh, North Carolina, United States

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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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