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Engineer MSAT Validation

Panda International

ph3🧬Supporting Technical Operations Leaders to Build High-Performing Biopharma Teams | Recruitment Consultant @ Panda /h3 pbJob Description /b /p pThe 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. /p pIn 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. /p ul libEducation: /b Bachelor’s degree (or equivalent) in a Science, Engineering, or Technical subject. /li libExperience: /b Minimum of 4 years of relevant experience in the (bio)pharmaceutical industry or related academic experience. /li libCore technical expertise: /b Knowledge of regulatory requirements and industry guidelines (FDA, EMA, ICH, ASTM, ISO, ISPE, PDA). /li libRequired hands‑on skills: /b Writing and reviewing validation protocols/reports; planning and coordinating validation studies. /li libRequired scientific/technical knowledge: /b Understanding of risk management, root‑cause problem solving, and Good Documentation Practices (GDP). /li /ul pbPreferred Requirements /b /p ul libAdditional experience: /b Previous experience in a Manufacturing Science Technology (MSAT) environment. /li libAdvanced technical skills: /b Proficiency in 6‑Sigma/Lean or similar continuous improvement methodologies. /li libSpecific technologies or platforms: /b Experience in cleaning validation, mixing validation, sterilization qualification, or holding time studies. /li libIndustry or domain exposure: /b Experience with biotherapeutic drug substance manufacturing. /li libSoft skills or certifications: /b Strong stakeholder management and communication skills. /li /ul pbPracticalities /b /p ul libStart Date: /b January 1, 2026 /li libContract Duration: /b 12 Months /li libLocation: /b Leiden, the Netherlands /li libAdditional: /b 40 hours per week; competitive hourly rate. /li /ul pbInterested? /b /p pInterviews and offers can move quickly. Send your CV to Oluali Titelman at or call +31 (0) today to secure your spot in the process. /p pbSeniority level: /b /p ulliMid‑Senior level /li /ul pbEmployment type: /b /p ulliFull‑time /li /ul pbJob function: /b /p ulliManufacturing, Science, and Strategy/Planning /li /ul pbIndustries: /b /p ulliBiotechnology Research and Pharmaceutical Manufacturing /li /ul /p #J-18808-Ljbffr

Vacature geplaatst op 3 dagen geleden
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