Lead Validation Specialist, Haarlem, Noord-Holland

The Company
A leading organization in the pharmaceutical sector, committed to maintaining the highest standards of quality, compliance, and operational excellence. They focus on innovative solutions and continuous process improvements to ensure the delivery of safe and effective healthcare products.

About the Role:
The Senior Validation Expert is responsible for leading and executing validation and re-qualification activities for critical pharmaceutical equipment and systems to ensure regulatory compliance and product quality. The role involves planning and performing IQ, OQ, and PQ, managing deviations, and supporting CAPAs and changing controls. You will provide technical expertise on complex validation projects, including sterilizers, lyophilizers, depyrogenation tunnels, and airflow studies.
 
Responsibilities:
- Lead equipment and system qualification activities (IQ, OQ, PQ) to ensure compliance with GMP, regulatory standards, and internal quality requirements.
- Plan and execute validation and re-qualification protocols for critical pharmaceutical equipment such as sterilizers, lyophilizers, depyrogenation tunnels, and airflow visualization systems.
- Manage deviations, CAPAs, and change controls, ensuring proper documentation, root cause analysis, corrective actions, and timely closure.
- Review and approve validation documentation and data, including protocols, reports, risk assessments, and periodic review records to ensure regulatory compliance.
- Support audits, inspections, and cross-functional collaboration, acting as a Subject Matter Expert (SME) and mentoring junior validation team members.
 
Requirements:
- Bachelor’s or Master’s degree in Engineering, Pharmacy, Life Sciences, or a related scientific discipline.
- 4–6+ years of experience in Validation/CQV within the pharmaceutical or other highly regulated industries.
- Strong expertise in GMP, GDP, and regulatory compliance, including experience with IQ, OQ, and PQ activities.
- Hands-on experience validating pharmaceutical equipment and systems, such as sterilizers, lyophilizers, depyrogenation tunnels, and critical utilities.
- Excellent analytical, documentation, and communication skills, with proven ability to manage deviations, CAPAs, audits, and cross-functional collaboration.
 
Other Information:
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