MES Engineer (Pharmaceutical, Remote)

Job summary

Seeking an experienced MES Engineer with expertise in Werum PAS-X and Core 3 configuration to enhance and support MES solutions in a regulated pharmaceutical or biotech manufacturing setting.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field.
• Strong hands-on experience with Werum PAS-X MES and proven experience with PAS-X Core 3.
• Background in pharmaceutical or biotech manufacturing environments with a solid understanding of GMP-regulated systems and validation lifecycle.
• Familiarity with electronic batch record design and execution, as well as ISA-95 concepts.

Responsibilities

• Design, configure, and support Werum PAS-X MES solutions in GMP manufacturing environments.
• Develop and maintain functionalities including Master Batch Records (MBRs), Electronic Batch Records (EBRs), and workflow configuration.
• Collaborate with Manufacturing, QA, Validation, Automation, and IT teams.
• Support MES deployment activities, including commissioning, qualification, and validation.
• Execute testing activities such as FAT, SAT, IQ/OQ support, and user acceptance testing.
• Troubleshoot MES issues and provide ongoing operational support.
• Participate in change control, deviation investigations, and CAPA activities.
• Ensure compliance with GMP, GAMP5, and 21 CFR Part 11 requirements.
• Support integration activities between MES and adjacent systems like SAP, LIMS, DeltaV, or SCADA platforms.
• Create and maintain technical and functional documentation.

Skills

• Excellent problem-solving and stakeholder communication skills.

Tools

• Experience with PAS-X upgrades, SAP integration, and familiarity with serialization, recipe management, or automation systems. Exposure to DeltaV, Siemens, Rockwell, or other automation platforms is preferred.