Senior GMP Validation & Calibration Specialist (On-site)

Real; Boxmeer; On-site; EUR 80,000 - 110,000; Full time

Job summary

Real is seeking a Senior Validation & Calibration Specialist to join the Operational Services team in Boxmeer, Netherlands, on-site. The role requires coordinating and executing GMP validation, qualification, and calibration activities in a manufacturing setting, reporting findings, and driving improvements.

You will collaborate with engineering, operations, quality, suppliers, and process owners, ensuring robust documentation and readiness for audits and inspections.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Technology, or a related discipline.
• Minimum 5 years of experience within the pharmaceutical industry or GMP-regulated environments.
• Proven experience with validation, qualification, and calibration processes.
• Strong knowledge of GMP regulations and compliance requirements.
• Experience writing and reviewing technical documentation and reports.
• Fluent Dutch and English; Dutch language proficiency is required.

Responsibilities

• Develop, review, and maintain validation, qualification, and calibration protocols.
• Prepare and review technical reports, documentation, and annual plans.
• Coordinate and execute validation and calibration activities in accordance with GMP requirements.
• Review qualification documentation and technical packages.
• Perform data analysis and maintain records within quality and CMMS systems.
• Act as SME for validation, qualification, and calibration topics.
• Support deviation investigations and change control activities.
• Collaborate with internal stakeholders, engineering teams, and external suppliers.
• Drive continuous improvement initiatives and procedural enhancements.
• Support internal and external audits and regulatory inspections.
• Ensure compliance with GMP, safety, quality, and environmental standards.

Skills

Validation & Calibration

GMP

Documentation

Cross-functional collaboration

Data analysis

Audits & inspections

Education

Bachelor's degree in Engineering/Life Sciences/Pharmaceutical Technology

Tools

CMMS

Job description

Real is seeking a Senior Validation & Calibration Specialist to join the Operational Services team in Boxmeer, Netherlands, on-site. The role requires coordinating and executing GMP validation, qualification, and calibration activities in a manufacturing setting, reporting findings, and driving improvements.

You will collaborate with engineering, operations, quality, suppliers, and process owners, ensuring robust documentation and readiness for audits and inspections.