Senior QA Validation Specialist

Hyper Recruitment Solutions Ltd; Limburg; On-site; EUR 70,000 - 110,000; Full time

Job summary

Hyper Recruitment Solutions Ltd is seeking a Senior Validation Specialist for a leading biopharmaceutical organization in the Netherlands. The role focuses on overseeing validation and qualification activities, ensuring cGMP compliance, regulatory alignment, and continuous improvement of validation processes.

You will manage URS, validation plans, and DQ/IQ/OQ/PQ deliverables, review equipment, facilities, and utilities validation, and collaborate with production and QA to drive lifecycle

Qualifications

• Degree in Engineering, Biology, Biomedical Science, Life Science or related field required.
• 5–10 years’ experience in validated GxP environments with strong validation knowledge.
• Experience managing validation lifecycle activities, risk assessments, deviations and change controls.

Responsibilities

• Oversee validation and qualification deliverables (URS, validation plans, DQ/IQ/OQ/PQ) with traceability.
• Review and approve validation documents for equipment, facilities and utilities ensuring compliance.
• Conduct periodic reviews of validated GxP assets and assess validation impact of changes.
• Support production and QA teams in validation activities and manage deviations and CAPAs.
• Contribute to continuous improvement and standardization of validation practices.

Skills

Validation

GxP

cGMP

Quality systems

Education

Bachelor's degree or higher in Engineering/Life Sciences

Tools

URS

DQ/IQ/OQ/PQ

CAPA management

Job description

ROLE OVERVIEW

We are currently looking for a Senior Validation Specialist to join a leading biopharmaceutical organization based in a dynamic and regulated industry. This is an exciting opportunity for a seasoned professional to oversee validation and qualification activities, ensuring compliance with cGMP, FDA, and European regulations while supporting quality assurance and operational excellence. In this role, you will play a critical part in managing validation lifecycle documentation, reviewing and approving equipment, facility, and utility validation deliverables, and driving continuous improvement initiatives to enhance validation processes and standards.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the Senior Validation Specialist will be varied; however, the key duties and responsibilities are as follows:

• Oversee validation and qualification deliverables, including URSs, validation plans, and qualification documentation (DQ, IQ, OQ, PQ), ensuring requirements traceability throughout the project life cycle.
• Review and approve validation lifecycle documents related to equipment, facilities, and utilities, ensuring compliance with cGMP and validation standards.
• Conduct periodic reviews of validated GxP equipment, facilities, and utilities, and perform validation impact assessments prior to implementing changes.
• Support production and technical teams in validation activities, manage deviations and CAPAs to maintain system integrity, and ensure deviations are well documented with corrective actions taken.
• As the Senior Validation Specialist, you will contribute to continuous improvement and standardization of validation practices.

ROLE REQUIREMENTS

• A Degree or higher level in Engineering, Biology, Biomedical Science, Life Science, or a related discipline.
• Extensive experience (5–10 years) working within validated GxP environments, with a strong understanding of validation methodologies, quality systems, and industry regulations.
• Proven expertise in managing validation lifecycle activities, risk assessments, deviations, and change controls within a regulated manufacturing setting.

WHAT’S IN IT FOR YOU?

Joining our client offers an excellent platform to develop your expertise in validation within a leading life sciences organization. You will have the opportunity to work on impactful projects, contribute to compliance and process improvements, and be part of a forward-thinking team committed to quality and innovation.

Key Words: Validation/ Specialist/ GxP/ cGMP/ Equipment/ Facilities/ Utilities/ Regulatory/ Quality/ Compliance/ Risk Assessments/ Deviations/ CAPA/ Continuous Improvement/ Life Sciences/ Manufacturing

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements.