MES Engineer - PAS X - CQV - 12+ Months- Europe

We are looking for an MES Engineer with CQV experience to join an exciting project at a global & prominent client. You support system delivery, validation, and installation activities in a highly regulated environment.

You will act as an Automation Subject Matter Expert (SME) across multiple work packages, supporting documentation, testing, and system readiness.

Key Responsibilities

• Review and approve project documentation, including:
• Functional Specifications
• Interface Agreements
• FAT/SAT reports
• Create and maintain documentation such as:
• IT Risk Assessments (ITRAs)
• Validation and Test Plans
• Participate in and support validation and testing activities:
• DQ, FAT, SAT, DERs
• Support system installation and commissioning activities
• Ensure all assigned activities are completed on time and with the right level of quality
• Complete required trainings according to project timelines
• Collaborate closely with internal teams, vendors, and stakeholders

Required Experience & Skills

• Good experience in automation within: Pharmaceutical or other regulated industries
• CQV experience (Commissioning, Qualification, and Validation)
• Experience with MES (PAS X Core 3) is a strong advantage
• Hands-on experience with: DQ, FAT, SAT processes
• Experience with API projects or manufacturing environments (preferred)
• Knowledge of ISA-88/Batch systems (preferred)
• Comfortable working as a hands-on project engineer

Contract details:

• Start date: ASAP
• Location: Hybrid - Kalundborg - Denmark
• Duration: 12months + (plus extensions)
• Salary/Hourly rate: Please let us know your expectations.

Interested? Please reach out directly with your updated CV

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