We are seeking an experienced MES Engineer with strong expertise in Werum PAS-X and Core 3 configuration to support the delivery, enhancement, and support of MES solutions within a regulated pharmaceutical/biotech manufacturing environment.
The successful candidate will work closely with manufacturing, quality, validation, and automation teams to design and implement robust MES solutions that support electronic batch records, process execution, and digital manufacturing initiatives.
- Design, configure, and support Werum PAS-X MES solutions within GMP manufacturing environments
- Develop and maintain PAS-X Core 3 functionalities including:
- Master Batch Records (MBRs)
- Electronic Batch Records (EBRs)
- Workflow configuration
- Materials and resource management
- Process parameter integration
- Master Batch Records (MBRs)
- Collaborate with cross-functional stakeholders including Manufacturing, QA, Validation, Automation, and IT
- 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 such as SAP, LIMS, DeltaV, or SCADA platforms
- Create and maintain technical and functional documentation
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related discipline
- Strong hands-on experience with Werum PAS-X MES
- Proven experience working with PAS-X Core 3
- Experience in pharmaceutical or biotech manufacturing environments
- Strong understanding of GMP-regulated systems and validation lifecycle
- Experience with electronic batch record design and execution
- Familiarity with ISA-95 concepts and manufacturing process integration
- Experience supporting commissioning and qualification activities
- Excellent problem-solving and stakeholder communication skills
- Experience with PAS-X upgrades or greenfield MES deployments
- Knowledge of integration technologies and interfaces
- Experience with SAP integration
- Familiarity with serialization, recipe management, or automation systems
- Exposure to DeltaV, Siemens, Rockwell, or other automation platforms
Skills Required
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or related discipline
- Strong hands-on experience with Werum PAS-X MES
- Proven experience working with PAS-X Core 3
- Experience in pharmaceutical or biotech manufacturing environments
- Strong understanding of GMP-regulated systems and validation lifecycle
- Experience with electronic batch record (EBR) design and execution and Master Batch Records (MBRs)
- Familiarity with ISA-95 concepts and manufacturing process integration
- Experience supporting commissioning, qualification, and testing activities (IQ/OQ, FAT, SAT, UAT)
- Excellent problem-solving and stakeholder communication skills
- Experience with PAS-X upgrades or greenfield MES deployments
- Knowledge of integration technologies and interfaces
- Experience with SAP integration
- Familiarity with serialization, recipe management, or automation systems
- Exposure to DeltaV, Siemens, Rockwell, or other automation platforms
What We Do
Horizon Controls Group: A global leader in automation consulting, enabling both clients and employees to live on the forefront of evolving technology. Horizon Controls Group is a modern, global technology company, specializing in automation consulting, engineering, and training. Founded on the belief that our people are the difference, we have grown entirely from customer references and successive projects. Our people and their established reputation are our most valued assets. This belief has created a great place to work, enabling us to attract the very best and to give our customers confidence in our superior solutions. Our business is comprised of excellence at every level. We employ a pro-active and comprehensive approach to projects -- asking the right questions, analyzing client needs, and engineering a skilled solution. We are committed to understanding the entire spectrum of your automation challenges and to developing uniquely tailored innovative solutions. Our decision to be vendor-independent enables us to offer tailored solutions and represent your needs free of any conflict of interest. We are aligned exclusively with our customers' goals and system requirements, enabling us to provide maximum value. Ultimately, the ability to harvest maximum value from new systems is dependent on the quality and training of your people. Just as we expect and ensure absolute expertise in our people, we work with you to ensure your team is trained to the specific needs of your organization and remain at the forefront of industry trends. We are a global company operating in the United States from our headquarters in Blue Bell, PA and offices in Indiana, Massachusetts, North Carolina, and California and from Cork in Ireland. This is Horizon Controls Group’s official company LinkedIn page.
