Instrument Validation Engineer (8 months contract)

• Eysins, Switzerland


• Contract

Company Description

Quotient is a commercial-stage diagnostics company committed to increasing efficiencies and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and donor disease screening (transfusion diagnostics), Quotient is developing MosaiQ™, its next generation automation platform to address the comprehensive needs of the global transfusion diagnostics market. Once approved for sale, MosaiQ™ will be the first fully automated solution for blood grouping, quickly and comprehensively characterizing both donor and patient blood, improving patient outcomes and eliminating the need for expensive and time-consuming manual testing. MosaiQ™ will also undertake all mandated serological disease screening tests required for donor blood. Quotient has over 30 years of experience developing, manufacturing and commercializing transfusion diagnostic products. The company’s operations are based in Switzerland, Scotland and the US.

Job Description

• Develop, document and execute validation protocols


• Determine revalidation requirements through Risk Assessment


• Manage all validation and qualification activities for the MosaiQ™ instruments


• Prepare associated reports and work progress updates


• Maintain the validated state of the instrument in the lab including maintenance / cleaning activities of analysers on a routine basis


• Define and implement Standard Policies and Procedures for instrumentation maintenance and Quality Control


• Review R&D protocols and reports to ensure scientific and quality objectives are achieved


• Be the interface between Instrument validation and all other necessary functions to ensure issues identified during validation are communicated effectively and managed to closure, meeting compliance and timeline needs


• Complete root cause investigations for non-conformances and deviations associated with the validation activities and identify and implement corrective actions as required


• Ownership and support of Corrective/Preventative Actions activities driven by the Quality system as required within the remit of work completed

Qualifications

• Master degree or equivalent diploma in Engineering, Science or related discipline


• Minimum 3 years validation experience in a regulated environment (e.g. medical device/pharmaceutical industry)


• Experience within a R&D development environment with knowledge of Design control processes


• A first-hand experience of audits by regulatory authorities is required


• Excellent decision-making ability and organisation skills


• Ability to self-manage and prioritise works based on project end date, thus ensuring projects delivered to schedule and budget


• Willingness and ability to collaborate with and influence other groups in a positive, team based environment


• Ability to communicate effectively both verbally and written in English and French

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