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Senior Process Engineer

Il y a 2 mois


Toulouse, Occitanie, France Evotec WD Temps plein
Job Title: Senior Process Engineer - New Product Introduction

We are seeking a highly motivated Senior Process Engineer to join our team at Just-Evotec Biologics. As a key member of our New Product Introduction (NPI) team, you will be responsible for leading activities related to the introduction of new products to our J.POD Toulouse biotherapeutics manufacturing facility.

Key Responsibilities:
  • Contribute to the development and implementation of NPI processes and procedures
  • Partner with cross-functional teams to ensure successful scale-up and transfer operations
  • Develop and maintain high-quality batch records and processes
  • Collaborate with Quality, CQV, and Global MSAT to develop and implement process validation and comparability study activities
  • Act as a subject matter expert to support regulatory and client inspection audits
Requirements:
  • Masters degree in a relevant field or related program
  • 5-10 years of pharmaceutical/biotech validation experience, including a minimum of 2 years of experience leading an NPI program for biopharmaceutical products
  • Strong background and technical mastery of purification and solution preparation operations using disposable-based manufacturing technologies
  • Leadership capabilities to contribute to building a high-performing team
Preferred Qualifications:
  • Experience in audits and inspections by health authorities and other external auditors
  • Familiarity with risk assessment and risk management for pharmaceutical products and processes
  • Experience in applying principles of Quality by Design