| Location | Breda, Netherlands |
|---|---|
| Business Sector | Biotechnology |
| Contact email | |
| Job ref | 26335 |
| Published | 5 days ago |
MES & Serialization Systems Engineer | Breda, Netherlands – Biopharmaceutical Packaging (GMP Environment)
Job Description
A leading biopharmaceutical organisation is seeking an experienced MES & Serialization Systems Engineer to provide technical leadership, system ownership and project execution for the site’s Manufacturing Execution System (Koerber PAS|X) and integrated platforms.
In this role, you will support both Commercial and Clinical packaging/labelling operations, ensuring seamless performance across MES, serialization, ERP and SCADA systems. You will own lifecycle management of assigned systems, drive continuous improvement, ensure compliance with GxP and global standards, and collaborate with cross-functional teams to optimise packaging-related business processes.
The position requires strong expertise in MES/Packaging Execution Systems, GMP environments, technical system integration and regulated manufacturing operations.
Degree in Computer Science, Information Systems, Engineering, Life Sciences, or equivalent industry experience
6+ years’ experience in application development, system administration or application support
Strong experience with MES & Packaging Execution Systems
Hands-on expertise in automation or equipment engineering within an IS (Information Systems) context
Experience working in cGMP-regulated manufacturing environments (preferably Packaging)
Familiarity with FDA cGxP, 21 CFR Part 11 and software validation
Knowledge of interfaces (e.g., OPC), data conversion, networking and infrastructure
Experience with Product Serialization
Ability to translate business requirements into IS/technical solutions
Strong understanding of business processes in a GMP packaging environment
Ability to independently manage multiple assignments with minimal supervision
Strong analytical skills, including trend analysis and risk assessments
Fluent English (written and spoken)
Experience with:
· Koerber PAS|X
· Systech Serialization (Guardian / Advisor)
· Rockwell FactoryTalk SCADA
· Aveva PI Data Historian
· Oracle, SQL, Unix/Linux
· ITIL framework (ITIL V3)
· Global pharma/biotech environments
· Technical support of operating packaging facilities (PLC/SCADA, DCS, OEM Automation)
Experience participating in regulatory and internal audits
Ability to guide, coach and share knowledge with team members
Strong communication skills for cross-functional collaboration
System Ownership & Support
Manage MES and Packaging Execution Platforms, including service requests, incidents and change requests
Own lifecycle management of assigned IS automation systems
Analyse, design and implement solutions for new requirements and site expansion
Ensure compliance with GxP, SOX, Data Privacy, Part 11 and global standards
Maintain system configuration and documentation (SOPs, specifications, administration procedures)
Serve as the primary point of contact for application and infrastructure-related topics
Project Execution & Technical Leadership
Lead or support initiatives to enhance packaging operations and optimise system performance
Translate business requirements into technical designs/solutions
Develop project documentation and deliverables
Provide guidance and technical leadership to colleagues
Participate in audits; address findings and provide evidence
Client & Cross-Functional Collaboration
Attend and facilitate cross-functional meetings to optimise business processes
Understand and support local business processes and applications
Promote effective communication between business users, IS teams and external suppliers
Evaluate system/application performance and recommend improvements based on data and trends
Willingness to participate in on-call / after-hours support
Location: Breda, Netherlands
Industry: Biopharmaceutical Packaging / GMP Environment
Interested?
Interviews and offers can move quickly. Send your CV to Miguel Gomes at m.gomes@panda-int.com or call +31 (0)20 2044 502 today to secure your spot in the process.