Senior Qualification & Validation Expert León, Spain 26.01.2024 | [H-413]

Senior 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.As a successful Q&V Engineer, you will: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.Plan, develop, and execute Qualifications and Validations for Drug Substance Processes for our facility in Leon and globally.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 degree.A minimum of 5 years of experience in Qualification and Validation.Good understanding of manufacturing processes and related process equipment.Extensive experience in a regulated pharmaceutical environment and GMP requirements.Ability to prioritize and manage work to critical project timelines in a fast-paced environment.Structured, focused, and well-organized working attitude.Self-dependent way of working and taking ownership of assigned tasks.Working knowledge of quality systems and regulatory requirements across multiple health authorities.Proficient in Spanish and English.Ability to travel occasionally to different sites.Responsibilities include:Leading assigned Qualifications and Validations and providing guidance to local teams.Coordinating and communicating with stakeholders to ensure accurate and timely completion.Creating protocols and risk assessments for Qualification in accordance with policy and procedures.Creating protocols and risk assessments for Verifications & Validation (sterilization, decontamination, and process) in accordance with policy and procedures.Providing 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 Systems.Performing periodical assessment of validity of equipment qualification & validation / periodic reviews.Reviewing and analyzing related Deviations, CAPAs, and Changes.My reasons for choosing Bacthera..
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