Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.We are seeking an experienced Microbiology Expert to provide specialized scientific and technical support for the preparation of a proposal aimed at establishing a microbiota diagnostic line. The role involves advising on laboratory compliance, supplier audits, microbiological and analytical methodologies, laboratory management systems, and applicable regulatory requirements.Responsibilities- Provide expert input on the design, validation, and implementation of microbiological and analytical methods relevant to microbiota diagnostics.- Advise on laboratory setup, biosafety standards, and compliance with national and EU regulations.- Support the development and documentation of laboratory quality management systems (e.G., ISO 15189, ISO 17025, GLP).- Conduct or assist in supplier and service provider audits to assess technical capability and regulatory compliance.- Review microbiological protocols, analytical workflows, and data management practices to ensure scientific and operational robustness.- Contribute to the preparation of technical sections of the project proposal and regulatory documentation.- Collaborate with multidisciplinary teams (R&D, Quality, Regulatory Affairs) to ensure alignment of scientific and regulatory aspects.Qualifications- Advanced degree (PhD or MSc) in Microbiology, Molecular Biology, or a related life science field.- At least 5 years of professional experience in microbiological diagnostics, clinical microbiology, or biotech R&D.- In-depth knowledge of laboratory quality systems and relevant regulatory frameworks (EU IVDR, ISO 15189, or equivalent).- Proven experience in developing or validating microbiological and analytical methods.- Familiarity with supplier auditing and laboratory management systems.- Strong analytical, organizational, and reporting skills.- Excellent command of English (Spanish is an asset).- Ability to work independently and provide strategic scientific guidance within a project-driven context.Next StepsUpon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome from the Hiring Manager interview, the recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.Working at PQE GroupAs a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills, and interact with colleagues from all corners of the world.If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.Apply now and take the first step towards an amazing future with us.
Expert • Madrid, Kingdom Of Spain, España