Description

AliveDx, we empower diagnostic insights, transform care, and for life. With over 30-years in in-vitro diagnostics, we put the health of first by solutions designed for faster diagnostic results. Alba–– our blood bank reagents portfolio–– and MosaiQ®–– one of the first multiplexing and multimodality testing designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and Quotient. Today, as AliveDx, we for & & ENGINEER – TEMPORARY UNTIL END AliveDx is recruiting for a & Engineer to join our Engineering team – a key function ensuring systems, equipment, and processes are compliant, reliable, and fit for purpose across the product lifecycle. The role is a full-time X until end of based in Eysins, MISSIONAs a & Engineer, you will be responsible for defining, executing, and documenting and activities to equipment, utilities, facilities, computerized systems, and manufacturing will ensure compliance with GMP, FDA, ISO, and internal quality requirements while supporting excellence and maintaining systems X in a and inspection-ready throughout their will :Develop, and implement analytical methods supporting product development, manufacturing, and and execute and for equipment, systems, utilities, and manufacturing and perform X including IQ/OQ/PQ, process and activitiesDraft and maintain including URS, risk assessments, protocols, reports, SOPs, and technical proceduresEnsure activities and comply with GMP, GDP, FDA, ISO, and internal quality closely with Engineering, Manufacturing, QA, and QC teams X of new equipment and process improvementsSupport root cause analysis, CAPA, and change control activities impacting in audits, inspections, and continuous improvement to maintain and complianceThis role requires strong technical expertise, to detail, and the ability to work cross-functionally in a environment to ensure product quality, safety, and COMPETENCIESBachelor or Master degree in Engineering, Life Sciences, or fieldMinimum 2–5 years of experience in within a industry (medical devices, pharma, biotech)Strong knowledge of GMP, GDP, FDA, and ISO requirements and quality systemsExperience in drafting and reviewing technical and GMP X and lifecycle methodologies and risk-based approachesExperience with CAPA, and Change Control processesStrong analytical, and problem-solving skills with the ability to manage multiple prioritiesFluent in French and English (written and WE OFFERA highly dynamic and growing environment,An opportunity to live your passion for an intrapreneurial mindset, where and customer centricity heart of everything we do,A flexible working environment where applicable and a range of core and flexible benefits, ranging from X support, additional annual leave, cycle to work scheme, technology and access to marketplace discounts.Interested? We invite you to send your including your resume X other relevant documents. We look forward to exploring your potential contributions to AliveDx.AliveDx is an equal opportunity employer and welcomes from X individuals regardless of sex, disability, religion/belief, sexual or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs. jid5099c72aen jit0624aen jpiy26aen