Equipment & Qualification Engineer M/F
About AbbVie AbbVie's mission is to discover and produce innovative medicines that provide solutions to today's serious health problems while meeting tomorrow's medical challenges. We seek to transform people's lives in several key therapeutic areas such as immunology, oncology, neuroscience, ophthalmology, virology, in addition to the products and services within our Allergan Aesthetics portfolio. We are proud to be a Great Place to Work company.
Join us by joining the 3rd largest pharmaceutical laboratory in the world and a growing site between lake and mountains! A leader in medical aesthetics, Allergan, a subsidiary of the AbbVie Group, develops and manufactures sterile injectable products based on hyaluronic acid for aesthetic facial treatment, thereby contributing to patient well-being. Our ambition? To offer the best innovation in the aesthetic medicine market. As part of a new position creation, we are recruiting for our R&D department, based in our center of excellence for aesthetic medicine in Annecy, Haute-Savoie: An Equipment & Qualification Engineer in CDI (Permanent Contract) Reporting to the Lab Manager, you are the referent for the R&D equipment qualification process. In this capacity, you will lead qualification projects from the definition of user needs to obtaining the validated state. You will define and monitor the Site Validation Master Plan (SVMP) for R&D activities and support teams in the implementation of qualification strategies. You will work on equipment and systems in collaboration with R&D teams, support functions, suppliers, and other site stakeholders.
Your main responsibilities: Define equipment qualification strategies in collaboration with the qualification team members. Develop, maintain, and deploy R&D equipment qualification standards, in consistency with Group standards. Ensure normative and regulatory monitoring in your field of expertise and implement necessary actions. Train and support team members on the equipment qualification process. Lead and coordinate Change Control processes related to the qualification of complex systems. Write and/or review technical and operational qualification documents. Participate in, supervise, and/or perform commissioning, qualification, and requalification tests.
You possess assets to join us: A higher scientific education at the Master's level (Bac+5), ideally in engineering, science, or a comparable technical field. At least 8 years of experience in equipment qualification within the pharmaceutical industry, medical devices, or a comparable regulated environment. Proven experience in technical project management and in coordinating internal and external stakeholders. Proficiency in professional English, both written and spoken. Excellent analytical, synthesis, and writing skills. The ability to communicate with various interlocutors and to work in a team. Rigor, organizational skills, and attention to documentary quality. A spirit of initiative, technical curiosity, adaptability, and the ability to support change.
AbbVie is an equal opportunity employer and is committed to acting with integrity, driving innovation, transforming lives, and serving our community. Equal opportunity employer for veterans and people with disabilities.