For a well-established global consulting company , we are currently looking for an experienced MES (PAS‑X) Consultant to support a project in the pharmaceutical environment.

In this role

You will support the upgrade and optimization of a Manufacturing Execution System (PAS‑X) within a highly regulated life sciences environment.

Tasks

• Provide technical support for and execute a version upgrade of the Koerber PAS-X MES system
• Analyze the existing system landscape and assess upgrade impacts (GMBRs, configuration, functionalities, interfaces etc.)
• Perform system configuration, customization and integration within existing IT/OT architectures
• Support the creation/ update of system documentation
• Plan and execute computer system validation (CSV) activities in accordance with GxP requirements:
• Preparation of validation documentation (URS, FS/DS, IQ/OQ/PQ)
• Support of risk assessments
• Test case design, execution and documentation
• Preparation and execution of Site Acceptance Tests (Acceptance Tests Customer)
• Cut-over planning and execution
• Hypercare-support after Go-live
• Perform troubleshooting and root cause analysis in the MES environment

Your Profile

• Degree in Computer Science, Engineering, Life Sciences, or a comparable qualification
• Solid experience in MES environments, especially with PAS-X
• Proven experience with system upgrades and migrations
• Solid knowledge of GxP-regulated environments (pharmaceutical / life sciences)
• Strong experience in computer system validation (CSV) is required
• Technical understanding of system interfaces (e.g., SAP, eLIMS, Aveva PI and different systems)
• Experienced in: SQL and database technologies and interface technologies
• Strong analytical skills and a structured, quality-focused working style
• Fluent in English; German is an advantage

General Conditions

Start: ASAP

Workload: 100%

Location: Basel