Product Validation Engineer Immuno-Assay (BBBH286929) Vaud, Suisse
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