Senior Validation & Calibration Specialist - GMP On-site

Real

Boxmeer

On-site

EUR 65,000 - 90,000

Full time

7 days ago
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Job summary

Real, a leading pharmaceutical organization, seeks a Senior Validation & Calibration Specialist to join its Operational Services team in Boxmeer, Netherlands. This on-site role coordinates, executes, reviews, and reports validation, qualification, and calibration activities within a GMP manufacturing environment.

The ideal candidate will act as SME, work with engineering, operations, quality, and suppliers; ensure compliance, documentation, audits support, and continuous improvement.

Qualifications

  • Bachelor's degree in Engineering, Life Sciences, or related discipline.
  • Minimum 5 years in pharma or GMP-regulated environment.
  • Proven validation, qualification, and calibration experience.
  • Strong GMP knowledge and documentation skills.
  • Fluent Dutch and English; Dutch mandatory.

Responsibilities

  • Develop, review, and maintain validation, qualification, and calibration protocols.
  • Prepare and review technical reports and annual plans.
  • Coordinate validation and calibration activities per GMP.
  • Review qualification documentation and technical packages.
  • Perform data analysis and maintain records in quality/CMMS systems.
  • Act as SME for validation topics.
  • Support deviation investigations and change control.
  • Collaborate with engineers, operations, quality and suppliers.
  • Drive continuous improvement and procedural enhancements.
  • Support audits and regulatory inspections.
  • Ensure GMP, safety, quality and environmental standards.

Skills

Analytical skills
Problem-solving
Independent working
Documentation skills

Education

Bachelor's degree in Engineering/Life Sciences/Pharma

Tools

CMMS systems
Document control systems
Validation software

Job description

Real, a leading pharmaceutical organization, seeks a Senior Validation & Calibration Specialist to join its Operational Services team in Boxmeer, Netherlands. This on-site role coordinates, executes, reviews, and reports validation, qualification, and calibration activities within a GMP manufacturing environment.

The ideal candidate will act as SME, work with engineering, operations, quality, and suppliers; ensure compliance, documentation, audits support, and continuous improvement.

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