MS Process Engineer

vor Gesendet 11 Stunden E-Mail Job
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Job Detail

  • Job-ID 302102

Job-Beschreibung

CK QLS are looking for a senior process engineer, to join a global pharmaceutical company, based in Neuchatel, on a contract basis for 12 months.MS Process Engineer Formulation, Fill and Finishing, NeuchatelDuration: 12 monthMain Responsibilities:

  • Manufacturing support activities (deviation, process follow-up) 45% of the responsibilities.
  • Projects management represents 45% of the responsibilities.
  • Audit and Regulatory questions related activities represents 10% of the responsibilities.

Further Responsibilities:

  • 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.

Candidate’s requirements:

  • 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.
  • 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.

Apply:If you are interested, you can send a CV in English to aguimard@ckqls.ch. Please quote job reference 108 313 in all correspondence.

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