Equipment Validation Specialist, Breda, Noord-Brabant

Company
A leading organization in the pharmaceutical and biotech industry, dedicated to advancing healthcare through innovative product development and rigorous quality standards. The company values compliance, continuous improvement, and a collaborative work environment.

Job Description
We are seeking a dedicated Equipment Validation Specialist to support and oversee validation activities related to equipment, automation systems, and information technology within a GMP-regulated setting. This role involves ensuring compliance with all relevant standards, reviewing validation documentation, and providing guidance to operational teams to uphold quality policies.

Responsibilities

• Support and oversee validation of process equipment, automation, and information systems, aligning design, characterization, and validation strategies with GMP and regulatory requirements.
• Review and approve validation documents for equipment and automation systems, ensuring adherence to corporate, site, and regulatory standards.
• Provide expert guidance to operations staff regarding compliance with quality policies, standards, and procedures.
• Support maintenance and engineering activities, reviewing changes to equipment parameters, processes, and procedures for compliance and validation integrity.
• Manage device responsibilities within the context of combined products, ensuring GMP compliance and proper documentation.
• Represent QA in Quality Risk Management activities, including pFMEA, QRAES, and computer system validation, ensuring site activities align with corporate policy.
• Perform final reviews of technical change controls, assessing stakeholder inputs and ensuring proper documentation of all evaluations.
• Act as a subject matter expert for QA, collaborating across teams to support validation efforts and technical assessments.

Requirements

• Degree in Engineering, Pharmaceutical Sciences, Process Technology, or a related field.
• Between 5 to 8 years of professional experience within a GMP environment.
• Proven experience in equipment and automation validation, including systems compliance with GMP Annex 11/Part 11.
• Strong knowledge of quality risk management tools such as FMEA.
• Experience with statistical tools for sampling plans, hypothesis testing, and data analysis.
• Excellent communication skills, attention to detail, and ability to interpret complex situations.
• Demonstrated teamwork skills and a solution-oriented mindset.

Other Information
If you are interested and want to apply, please submit your application via the apply button.

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