Downstream Process Engineer/Downstream Manufacturing Process Specialist

Downstream Process Engineer/Downstream Manufacturing Process Specialist

Sanofi

Vitry-sur-Seine, France

KEY RESPONSIBILITIES:

  • Manages process fit-gap assessment in tech transfer team for purification, formulation and filling processes and identify areas requiring mitigation via process adaptation or facility modification;
  • Leads process validation including strategy definition, the execution follow-up and documentation management;
  • Defines and maintains the process control strategy for DSP;
  • Routinely monitors DSP manufacturing process and identify trends and resolves using her/his expertise and site resources, where possible, or escalate to MSAT governing body requiring additional expertise and resources;
  • Leads DSP process related complex problem investigation at the site by using solid process understanding and use of scientific and engineering principles and practices and facilitates generation of practical solutions;
  • As an downstream processing SME, provides technical support during health authority inspection;
  • Drives continuous process robustness and improvement in order to make processes more cost effective at the same time maintaining quality and HSE requirements;
  • Develops connection within global MSAT in international context.

BASIC QUALIFICATIONS:

  • Master’s Degree or PhD in engineering or science with minimum 5 years of experience in cGMP manufacturing environment or biologics process development.

REFERRED QUALIFICATIONS:

  • Strong experience in process development, process characterization, technology transfer and process validation in bio-manufacture industry;
  • Knowledge of purification technologies and operations;
  • Knowledge of viral clearance of purification processes;
  • Experience with automated protein purification chromatography and UF/DF;
  • Experience with DeltaV Process Control system;
  • Experience in cGMP and good understanding of regulatory requirements for biologics manufacturing;
  • Strong knowledge in data management and statistical analysis;
  • Proficiency with MS Office (Excel, Power Point, Word);
  • Ability to make a significant contribution to cross-functional project teams through technical expertise and scientific creativity;
  • Team player, ability to work effectively in a highly collaborative and dynamic environment;
  • Excellent communication skills;
  • Fluent in French and English.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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