(Senior) Validation Engineer

Role description

Summary of Role

Under the direction of the Engineering Manager, the (Senior) Validation Engineer will:

• Manage the site validation system according to the company’s quality objectives and the quality plan.
• Organize validation activities deployment and ensure the closed-loop of the validation work.
• Lead validation continuous improvement.

Key Responsibilities

• Manage the site validation system according to the company’s quality objective and quality plan.
• Manage the overview of the state of validation at the site; ensure that all processes, materials, equipment and facilities are properly qualified and validated.
• Maintain local procedures & templates for validation documentation and the validation master plan according to global quality directives / standard / guidance / cGMP and other local requirements together with other departments.
• Maintain the validation master plan (VMP) and procedures, and ensure alignment with the company’s quality management system.
• Establish and monitor metrics and data for qualification and validation activities, identify trends and issues, and conduct periodic reviews and re-validations as necessary.
• Develop the strategy for continued process verification and annual monitoring; ensure the plan is in place and that all critical process parameters and quality attributes are monitored or analyzed.
• Maintain all validation activities in an inspection-ready status ahead of any internal or external audits.
• Establish and monitor key performance indicators (KPIs) and metrics for qualification and validation; report on performance and effectiveness.
• Ensure proper documentation and review qualification and validation deliverables such as validation plans, risk assessments, traceability matrices, test scripts, deviations, and summary reports.
• Oversee the execution of qualification and validation studies.
• Draft and review protocols and reports for equipment, facility, utility, process validation/verification, cleaning validation, etc., and assist in their implementation.
• Review Test Method Validation (TMV) and Computer System Validation (CSV) protocols and reports.
• Manage the validation deviation process and VD logbook.
• Identify and drive continuous improvement initiatives and projects to enhance qualification and validation efficiency and effectiveness, fostering a culture of continuous improvement.
• Evaluate and recommend new technologies, tools, and methods to enhance qualification and validation processes and outcomes.
• Follow up on validation-related nonconformities (NC) and corrective & preventive actions (CAPA), ensuring they are completed on time.

Qualifications / Experience

• A relevant Bachelor’s/Master’s degree in Manufacturing, Engineering, or Sciences.
• Class III sterile medical device experience; familiarity with ISO 13485 and ISO 14971. Medical device or pharmaceutical industry experience preferred.
• Good experience and understanding of ISPE C&Q and validation.
• Minimum of 5 years of validation experience.
• Knowledge of quality regulations and policy; project management experience.
• Fluency in English; knowledge of Dutch preferred.
• Ability to work cooperatively with internal and external stakeholders.
• Ability to perform duties in accordance with policies and procedures.
• Ability to build strong working partnerships, trust, and credibility at all levels.
• Organizational, collaborative, communication, and leadership skills.

Preferred Skills

• Analytical reasoning, Auto-CAD design, design thinking, execution focus, industrial hygiene, issue escalation, lean supply chain management, mechanical engineering, problem solving, product reliability, project engineering, project management, project management methodology (PMM), quality control (QC), regulatory compliance, safety-oriented, STEM application, technical credibility, technologically savvy.

Fully Onsite Location: Nijmegen, NL