At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. GMP Validation and Qualification Expert Expert (all genders) You take on the independent management of validation activities and validation projects at the PSDC Darmstadt, including the planning, execution, and timely completion of validations, as well as the preparation of validation plans and reports You independently carry out qualification activities at the PSDC Darmstadt, including the planning, execution, and timely completion of qualifications, as well as the preparation of qualification plans and reports You independently perform CSV (Computerized System Validation) and are responsible for ensuring data integrity within production, including the creation of the associated documentation You take on the independent management and coordination of product and process optimization projects within production as part of CAPA or change measures You act as a project manager within production in cross-functional teams for internal and external projects, as well as for transfer projects and project strategies You ensure GMP compliance within production and GMP-compliant documentation of the work performed, as well as the creation and maintenance of Standard Operating Procedures (SOPs) and risk analyses You create change requests and deviations and process deviations and CAPAs for the Technical Operations department You conduct internal GMP training and participate in GMP inspections as an SME You hold a completed degree in a natural science or engineering discipline, e.g., Pharmacy, Biotechnology, Chemical Engineering (Master's level) You bring several years of professional experience (3-5 years) in the pharmaceutical industry You possess very good knowledge of cGMP regulations as well as process technology and operational workflows in pharmaceutical production You have experience in process and cleaning validation of pharmaceutical processes and in the development of cleaning procedures for equipment You have solid knowledge in CSV and data integrity You demonstrate a very high level of initiative, commitment, and creativity You have strong communication and organizational skills, enthusiasm, and enjoy working as part of a team You have excellent German and English language skills, both written and spoken Darmstadt,Hessen,Germany Our benefits package is flexible, appreciative, and tailored to your lifestyle, because: What matters to you, matters to us! \We ensure yourfinancial stability* through a competitive compensation package, consisting of an attractive base pay and our annual bonus. In addition, managers can recognize special contributions by granting an individual performance award or top performance award. \Whether it'shybrid work* models or part-time arrangements: Whenever it is possible, you will have the flexibility to work how, when and where it is best for you. \Yourfamily* is a top priority. We offer loving company daycare centers at multiple locations, support in finding childcare, time off for the care of elderly or dependent family members, summer camps for children, and much more. \We support yourprofessional growth* by providing access to learning and development opportunities, training programs through the Bayer Learning Academy, development dialogues, as well as coaching and mentoring programs. \We promotehealth* awareness and opportunities for selfcare through various measures, such as free health checks with the company doctor. \We embracediversity* by providing an inclusive work environment in which you are welcomed, supported, and encouraged to bring your whole self to work. Be You. Be Bayer. Location: Germany : Hessen : Darmstadt Division: Consumer Health Reference Code: 860957
