.Senior Qualification & Validation ExpertSenior Qualification & Validation Expert (f/m/d) 100%Bacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Spain, Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.CREATE YOUR OWN FUTURE ASSenior Qualification & Validation Expert (f/m/d) 100%As a successful Q&V Engineer you ensure that Qualifications and Validations are performed according to global and local company policies and standards as well as legal requirements and requirements set by regulatory authorities. You are responsible for planning, developing and executing Qualifications and Validations for Drug Substance Processes for our facility in Leon and globally. You will report to the global Head of Engineering Quality.I bring with me...Bachelor or Master's degree in Engineering, Pharmaceutical Technology, Chemistry, Biotechnology or equivalent scientific degreeA minimum of 5 years of experience in Qualification and ValidationGood understanding of manufacturing processes and related process equipmentExtensive experience in a regulated pharmaceutical environment and GMP requirementsAbility to prioritize and manage work to critical project timelines in a fast-paced environmentStructured, focused and well-organized working attitudeSelf-dependent way of working and taking ownership of assigned tasksWorking knowledge of quality systems and regulatory requirements across multiple health authoritiesProficient in Spanish and EnglishAbility to travel occasionally to different sitesLeads assigned Qualifications and Validations and provides guidance to local teamsCoordinates and communicates with stakeholders to ensure accurate and timely completionCreation of protocols and risk assessments for Qualification in accordance with policy and proceduresCreation of protocols and risk assessments for Verifications & Validation (sterilization, decontamination and process) in accordance with policy and proceduresProvides expertise on process & equipment capabilities on a wide variety of production equipment for Active Pharmaceutical Ingredient (API) and Drug Product (DP) as well as Media and HVAC SystemsPerforms periodical assessment of validity of equipment qualification & validation / periodic reviewsReviews and analyzes related Deviations, CAPAs and ChangesMy reasons for choosing Bacthera..
