266 Engineer jobs in the Canton of Vaud

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Product Validation Engineer Immuno-Assay

13.08. | Employee | 100%

Product Validation Engineer Immuno-Assay

Kelly Scientific is looking for a Product Validation Engineer - Immuno-assays for its medical partner.
(Permanent position)

Missions

  • You will be support the validation activities for the developped products
  • You will realise product validation plans, meet the project planning and collaborate with team members on building and maintaining the schedule.
  • You will be responsible for providing necessarily support for the investigations related with the activities required by the product validation team.


Responsibilities:

  • Understand Product performance validation activities and associated immuno-assays performance design inputs.
  • Support successful Product lifecycle development with a specific focus on assay performance requirements for a development, verification, validation and associated technical file construction.
  • Align with project planning on timelines and milestones and identify critical path items; with early issue escalation when required.
  • Execution of scheduled activities in compliance with existing internal policies and procedures.
  • Create and document product test studies and provide feedback and recommendations for product/design changes.
  • Collaborate with other teams to ensure that product requirements are testable and measurable.
  • Provide the technical support for the investigations related with the product performance.
  • Participate in Design Review to ensure key milestone deliverable are achieved.
  • Work as a team member to ensure that scientific and cooperate goals and objectives are met.
  • Comply with department and company training requirement.
  • Participate in risk management to all aspects of product development including process risks and product risks.
  • Perform any other duties as reasonably requested from the company from time to time (participation in workshops/ assisting in verification activities).


Profile :

  • Bachelor, Master or PhD in Biochemistry, Biology, Bioengineering or equivalent
  • Minimum 3 years' experience in pharmaceutical, biotechnology or medical device industry within a GMP environment
  • Extensive experience with R&D development environment with knowledge of design control processes
  • Knowledge in blood processing and diagnostic techniques
  • Fluent in English or French and professional command of the second language


Your contact at Kelly:
Mrs Karine Legerot
Consultant Professional Staffing Life Science
Kelly Scientific Geneva