We are seeking an experienced MES Engineer to support system enhancement, validation, and operational activities within a GMP-regulated pharmaceutical or biopharmaceutical environment. The role will focus on delivering MES improvement projects, executing computer system validation activities, and providing day-to-day system support.
Key Responsibilities
- Support MES (Werum Pas-X) enhancement and continuous improvement projects from requirements gathering through implementation.
- Work closely with manufacturing, automation, quality, IT, and external vendors to define and deliver system requirements.
- Execute validation activities using Kneat, including IQ, OQ, and PQ protocols.
- Prepare, review, and update validation and project documentation, including User Requirement Specifications, validation plans, test scripts, reports, and traceability documents.
- Support system configuration, testing, deployment, and change-control activities.
- Provide operational MES support, comprising approximately 30% of the role.
- Monitor MES system performance and status to ensure system availability and reliability.
- Investigate and troubleshoot system issues, coordinate incident resolution, and escalate technical problems where required.
- Ensure all MES enhancements and validation activities comply with GMP, data integrity, and computer system validation requirements.
- Maintain accurate documentation and support audits, inspections, and periodic system reviews.
Requirements
- Degree or Diploma in Engineering, IT, Computer Science, or a related field.
- 1–3 years of experience in MES, automation, validation, or pharmaceutical manufacturing.
- Exposure to Siemens MES or Werum PAS-X is preferred.
- Familiarity with GMP, CSV, IQ/OQ/PQ, and Kneat is advantageous.
- Basic experience preparing documents such as URS, validation plans, and test protocols.
- Good troubleshooting, communication, and stakeholder coordination skills.
