MSAT Validation Engineer, Leiden, Zuid-Holland

The Company
The client is part of the global pharmaceutical company. The facility is focused on the development and manufacturing of biologic medicines, particularly in the fields of immunology, oncology, and infectious diseases. They specialize in producing large-scale biologic drugs, which are typically made from living cells and are used to treat complex diseases. 

Role Description
As an MSAT Validation Engineer, you will play a key role in ensuring robust, compliant, and efficient manufacturing operations for biotherapeutic drug substances. Embedded in the Manufacturing Science & Technology (MSAT) organization, you will be part of the Supporting Process Validation (SPV) team, acting as a technical expert for the validation of supporting manufacturing processes. The role combines hands-on validation execution with cross-functional collaboration, continuous improvement, and the introduction of new technologies, all with a strong focus on patient value and regulatory compliance. 

Key Responsibilities

• Planning, coordinating, and executing validation activities for manufacturing equipment and supporting processes, including cleaning, mixing, sterilization, and holding time studies.
• Developing, reviewing, and approving validation protocols and final reports in accordance with internal standards and regulatory expectations.
• Acting as the validation representative within project teams, ensuring timely delivery of validation milestones and providing clear, regular status updates.
• Collaborating closely with manufacturing, quality, engineering, and other stakeholders to align on execution planning, resource needs, and issue resolution.
• Proactively identifying, escalating, and supporting the resolution of technical or compliance risks related to validation activities.
• Contributing to inspection and audit readiness by supporting the validation of  documentation, execution evidence, and responses.
• Driving process optimization through continuous improvement initiatives, benchmarking, standardization, and the deployment of new or advanced technologies.
• Ensuring full compliance with company policies, procedures, and values, including Quality, Environmental Health & Safety, business standards. 

Requirements

• Bachelor’s degree (or equivalent) in a scientific, engineering, or other relevant technical discipline.
• At least two years of relevant experience within the (bio)pharmaceutical industry, or a combination of industry and applicable academic experience.
• Solid capabilities in technical documentation, planning and coordination, risk assessment, root cause analysis, and knowledge management.
• Working knowledge of pharmaceutical regulatory requirements and validation-related guidelines (e.g., FDA, EMA, ICH, ASTM, ISO, ISPE, PDA).
• Hands-on experience or demonstrated knowledge in the validation of manufacturing equipment and supporting processes, such as cleaning, mixing, and microbial or chemical holding time studies.
• Exposure to Lean, Six Sigma, or similar continuous improvement methodologies. 

Other information  
Apply to our vacancy for more information. Looking forward to getting in touch!

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