Process Engineer

il y a 1 semaine


Toulouse, Occitanie, France Just Evotec Biologics EU Temps plein
Job Title: Process Engineer - New Product Introduction

Just Evotec Biologics EU is seeking a highly motivated Process Engineer to join our team in Toulouse, France. As a Process Engineer, you will play a key role in leading activities related to the introduction of new products to our biotherapeutics manufacturing facility.

Responsibilities:
  • Contribute to leading Downstream stakeholders NPI process at J.POD Toulouse to support the start and rapid scale-up of commercial GMP manufacturing activities.
  • Partner with Product and Process Design to coordinate successful efficient scale-up and transfer operations and to ensure the successful integration of process knowledge into manufacturing operations.
  • Partner with supply chain to support Downstream Bill of Material development and demand planning for new products.
  • Partner with Process Engineering and Digital disciplines to conduct facility fit assessments and plans to support system updates needed for new product introduction.
  • Partner with Manufacturing to develop high-quality batch records, robust processes and innovative technology solutions for new product introduction.
  • Partner with Quality, CQV and Global MSAT to develop and implement process validation and comparability study activities leading to successful product registration.
  • Acting as a subject matter expert to support the team for regulatory and client inspection audits.
  • Utilize the team's technical skills and process knowledge to participate in investigations related to Downstream NPI activities. Collaborate with impacted groups to develop and execute effective CAPA.
  • Apply Operational Excellence principles to lead continuous improvement in NPI activities.
Requirements:
  • Masters degree in relevant field or related program with 5-10 years of pharmaceutical/biotech validation experience including a minimum of 2 years of experience leading a New Product Introduction program for biopharmaceutical products (Technology Transfer).
  • Experience with late-stage clinical and/or commercial biologics drug substance manufacturing programs, including process validation, PPQ, and potentially commercial manufacturing.
  • Proven record of accomplishment in GMP pharmaceutical or biotechnology is required.
  • Strong background and technical mastery of purification and solution preparation operations using disposable-based manufacturing technologies.
  • Leadership capabilities to contribute to building of a high-performing teams, to drive change, and influence internal and external stakeholders.
  • Knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing.
  • Good interpersonal, team, and collaborative skills are required.
  • Good verbal and written communication skills in French and English; ability to interface with all levels of the organization.

Just Evotec Biologics EU is an equal opportunities employer and welcomes applications from all qualified candidates. We are committed to diversity and inclusion in the workplace.


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