Senior Validation Engineer, Leiden, Zuid-Holland

The Company
Our client is a leading biopharmaceutical company based in Leiden, focused on developing and manufacturing innovative biologic medicines. They specialize in delivering high-quality therapies and driving advancements that improve global health and patient outcomes.

Role Description
As a Senior Engineer MSAT Validation you will responsible for leading and executing validation activities such as cleaning, mixing, sterilization, and holding time studies. The role ensures compliance with GMP and regulatory standards, supports process improvements, and contributes to new technology implementation within a biopharmaceutical manufacturing environment.

Responsibilities

• Lead, plan, coordinate, and execute validation activities such as cleaning validation, mixing validation, sterilization qualification, and holding time studies.
• Support definition of validation strategy and change control assessments.
• Write, review and approve validation protocols and reports.
• Support projects as extended project team member responsible for validation activities providing regular status updates in a timely manner. 
• Communicate with stakeholders to coordinate timing of execution and escalate issues. 

Requirements

• Bachelor’s or master’s degree or equivalent in Science, Engineering or Technical subject.
• Minimum 4 years of relevant experience in the (bio)pharmaceutical industry or related academic experience or education is required.
• Skills in communication, planning, good documentation practices, risk management, root cause problem solving and knowledge management. 
• Understanding of regulatory requirements and industry guidelines specific to the pharmaceutical industry and validation (e.g., FDA, EMA, ICH, ASTM, ISO, ISPE, PDA).
• Experience in qualification and validation (e.g., cleaning validation, mixing validation, sterilization qualification, holding time studies).

Other Information
Apply to our vacancy for more information. looking forward to hearing from you.

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