Return to search results

Engineer MSAT Validation

LocationLeiden, Netherlands
Business SectorBiotechnology
Contact email
Job ref26470
Published13 minutes ago

Engineer MSAT Validation

Leiden, the Netherlands – 1 Year

Job Description

The Manufacturing Science & Technology (MSAT) department is the leading partner in supporting process validation, technical product ownership, and a key driver of sophisticated technologies. You will drive technologies that enable high-value patient care at a growing biotherapeutic drug substance site.

In this role, you will focus on the validation of supporting processes (cleaning, mixing, sterilization, and holding time), while driving process improvements and new technology deployment. You will be responsible for planning and executing validation activities, maintaining compliance, and ensuring audit readiness through rigorous documentation and stakeholder communication.

Essential Requirements

  • Education: Bachelor’s degree (or equivalent) in a Science, Engineering, or Technical subject.

  • Experience: Minimum of 4 years of relevant experience in the (bio)pharmaceutical industry or related academic experience.

  • Core technical expertise: Knowledge of regulatory requirements and industry guidelines (FDA, EMA, ICH, ASTM, ISO, ISPE, PDA).

  • Required hands-on skills: Writing and reviewing validation protocols/reports; planning and coordinating validation studies.

  • Required scientific/technical knowledge: Understanding of risk management, root cause problem solving, and Good Documentation Practices (GDP).

Preferred Requirements

  • Additional experience: Previous experience in a Manufacturing Science & Technology (MSAT) environment.

  • Advanced technical skills: Proficiency in 6-Sigma/Lean or similar continuous improvement methodologies.

  • Specific technologies or platforms: Experience in cleaning validation, mixing validation, sterilization qualification, or holding time studies.

  • Industry or domain exposure: Experience with biotherapeutic drug substance manufacturing.

  • Soft skills or certifications: Strong stakeholder management and communication skills.

Practicalities

  • Start Date: January 1, 2026

  • Contract Duration: 12 Months

  • Location: Leiden, the Netherlands

  • Additional: 40 hours per week; competitive hourly rate.

Interested?

Interviews and offers can move quickly. Send your CV to Oluali Titelman at o.titelman@panda-int.com or call +31 (0)20 2044 502 today to secure your spot in the process.