Senior Qualification
hace 3 semanas
.Senior Qualification & Validation Expert 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.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..
-
Senior Qualification Expert
hace 1 semana
Leganés, Madrid, España Bacthera Ag A tiempo completoAbout Bacthera AgBacthera Ag 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.Job SummaryWe are seeking a highly skilled Senior Qualification Expert to join our team. As a successful Q&V Engineer, you will ensure that Qualifications and...
-
Senior Qualification Expert
hace 1 semana
Leganés, Madrid, España Bacthera Ag A tiempo completoAbout Bacthera AgBacthera Ag 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.Job SummaryWe are seeking a highly skilled Senior Qualification Expert to join our team. As a successful Q&V Engineer, you will ensure that Qualifications and...
-
Senior CSV Expert
hace 1 semana
Leganés, Madrid, España Bacthera A tiempo completoAbout the RoleBacthera 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. Our global presence spans across multiple locations, and we bring together best-in-class complementary capabilities.Job SummaryWe are seeking a highly skilled Senior...
-
Senior CSV Expert
hace 1 semana
Leganés, Madrid, España Bacthera A tiempo completoAbout the RoleBacthera 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. Our global presence spans across multiple locations, and we bring together best-in-class complementary capabilities.Job SummaryWe are seeking a highly skilled Senior...
-
Senior CSV Expert
hace 4 días
Leganés, Madrid, España Bacthera A tiempo completoAbout the RoleBacthera, a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers, is seeking a highly skilled Senior CSV Expert to join our team. As a successful CSV Engineer, you will play a critical role in ensuring that Computer System Validations are performed according to global and local company policies and...
-
Senior CSV Expert
hace 4 días
Leganés, Madrid, España Bacthera A tiempo completoAbout the RoleBacthera, a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers, is seeking a highly skilled Senior CSV Expert to join our team. As a successful CSV Engineer, you will play a critical role in ensuring that Computer System Validations are performed according to global and local company policies and...
-
Senior Csv Expert
hace 3 semanas
Leganés, España Bacthera Spain, Sl A tiempo completoAs a successful CSV Engineer you ensure that Computer System Validations are performed according to global and local company policies and standards as well as legal requirements and requirements set by health authorities. You are responsible for planning, developing and executing Computer System Validations for 4 Facilities. You will report to the global...
-
Senior Csv Expert
hace 4 semanas
Leganés, España Bacthera A tiempo completo.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...
-
Uat-669 - Senior Csv Expert
hace 5 días
Leganés, España Bacthera A tiempo completoBacthera 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...
