MES Engineer (Pharmaceutical)

Job summary

An experienced MES Engineer is needed to support the implementation and enhancement of MES solutions in a regulated pharmaceutical or biotech manufacturing setting. The role involves close collaboration with various teams to design and execute MES solutions that facilitate electronic batch records and digital manufacturing.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field
• Strong hands-on experience with Werum PAS-X MES
• Proven experience with PAS-X Core 3
• Background in pharmaceutical or biotech manufacturing environments
• Understanding of GMP-regulated systems and validation lifecycle

Responsibilities

• Design, configure, and support Werum PAS-X MES solutions in GMP environments
• Develop and maintain functionalities such as Master Batch Records (MBRs) and Electronic Batch Records (EBRs)
• Collaborate with Manufacturing, QA, Validation, Automation, and IT teams
• Support MES deployment activities including commissioning, qualification, and validation
• Execute testing activities including 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 and LIMS
• Create and maintain technical and functional documentation

Skills

• Excellent problem-solving and stakeholder communication skills

Tools

• Experience with integration technologies and interfaces, SAP integration, and familiarity with automation platforms such as DeltaV, Siemens, or Rockwell.