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MSAT Process Engineer

MSAT Process Engineer

ExperisNeuchâtel
Vor 14 Tagen
Stellenbeschreibung

MSAT Process Expert

On beahlf of our Pharmaceutical company in Neuchatel we are looking for a MSAT Process Expert with experience in MSAT Activities for a long term contract of 12 months and extension is highly possible.

General Information :

Start date : 06.01.2025

Duration : 12 months

Location : Neuchatel

Industry : Pharma

Hybrid role : 2 days per week on site but 1st 2 / 3 weeks on site full time to get to know team

Primary Duties

  • Lead process improvement projects or activities
  • Develop and optimize process parameters
  • Ensure process performances through Quality by Design (QbD) and Continuous Process Verification (CPV) approaches
  • Identify business opportunities
  • Ensure communication and act proactively in case of performance trending
  • Lead and / or support investigations related to deviation / CAPA process
  • Perform product impact assessment for deviation
  • Lead projects or activities related to FF process or equipment (from User Requirements Specifications to Process Performance Qualification)
  • Support validation activities
  • Support or present topic during regulatory inspections
  • Support technology transfer

Education and Experience

  • Minimum 3-5 years of experience FF area for recombinant protein.
  • Engineering or university degree in biotechnology
  • Language skills : Fluent in English and French
  • Knowledge of cGMP and quality requirements
  • Able to deal with statistics

    • Key Skills, Abilities, and Competencies

  • Strong energetic team player with good communication skills,
  • Ability to lead effectively and efficiently process validation topics
  • Ability to manage multiple priorities in a manufacturing plant setting
  • Ability to analyze, review and interpret validation data
  • Must have uncompromising dedication to quality and an excellent understanding of cGMPs and other regulatory guidelines
  • Interpersonal skills that enables you to work with people at all levels
  • Ability to plan, multitask, and manage time effectively
  • Must display eagerness to learn, to innovate, drive for solutions and continuously improvement
  • Able to deal in a matrix environment as well manage complex problem

    • If this job interests you please do send us your CV today through the link in the advert. However, should you have any questions please contact Elaine Kanwar elaine.kanwar(at) or at +41 61 282 22 23