Validation Engineer MSAT

Validation Engineer MSAT

Location: Sassenheim - Netherlands

Duration: until 31st December 2026

Hours: 40 hours contract role

The Validation Engineer MSAT is responsible for supporting Validation of supporting processes (e.g. Mixing, Sterilization, Bio-decontamination, Aseptic Process simulation, airflow visualization pattern), process improvements and standardization and/or technology implementation projects.

The Engineer Validation MSAT Advanced Therapies acts as Subject Matter Expert in one or more validation categories.

roles and responsibilities.

• Lead the execution of validation activities such as Bio-decontamination qualification, Aseptic process simulation, mixing validation, bio-decontamination, aseptic process simulation, and airflow visualization pattern.
• Write and review validation plans, protocols and reports.
• Communicate with stakeholders to coordinate timing of execution, provide status updates, and escalate issues.
• Act as Project Core Team Member for medium sized projects and as such:
• Define validation strategy.
• Represent MSAT in multidisciplinary team and align with extended team members.
• Plan and deliver team/project Goals and Objectives. Manage timelines and communicate project status.
• Provide direct input to resource planning.
• Act as SME for one or more validation categories. Leverage global MSAT network to identify and implement industry best practices.
• Participate in preparation and represent MSAT in audits/inspections
• Perform Change Control assessments and execute against assigned actions.
• Act as coach for more junior engineers.
• Maintain compliance with all company policies and procedures (e.g., Quality, EH&S, Business, Credo etc.)

Key Knowledge & Qualifications:

• Knowledge of and experience in a scientific or technical core area and building knowledge and experience in other technical and business disciplines.
• Proven experience with GMP and Quality Compliance.
• Precise, accurate, structured, flexible and customer focused.
• Capable of delivering local small projects, regional project work streams or departmental programs successfully under strong supervision.
• Bachelor's degree in a Science, Engineering or Technical subject and minimum 4 years of relevant experience in the (bio)pharmaceutical industry or related post graduate academic experience/education is required.

Languages:

Fluent in written and spoken English.