Validation Manager

Time for a change - time for a new job Are you a pharmacist looking for a new professional challenge in the pharmaceutical industry in Biberach ? We have what you are looking for: A secure job, attractive benefits and a job with exciting tasks as a Validation Expert . Apply online now and show us what you can do We value diversity and welcome all applications.

Here's what we offer

Attractive salary package with Christmas and vacation bonuses Contribution to company pension scheme after probationary period Personal advice with individual career planning Work in a fast-growing company with long-term prospects Monthly changing employee offers, e.g. for technology, fashion, cars, etc.

Your tasks

Assume independent responsibility for the support of products in the context of process and cleaning validation, including representation in interdisciplinary project team, compliance and customer meetings (internal or external) Coordination of validation activities Independent planning of process and cleaning validations, incl. creation, maintenance or revision of validation documents (validation master plans, validation reports, sampling plans, risk analyses) in coordination with relevant interfaces, such as production and analytical areas for process and cleaning validation, primarily in English, incl. cooperation in the event of associated deviations Independent research and GMP-compliant evaluation of analytical and operational results and data, e.g. from electronic systems Collaboration on control strategy, risk analysis and other documents in cooperation with the development unit, production, analytical units or other relevant interfaces Evaluation of changes in manufacturing/cleaning processes of products with regard to process and cleaning validation relevance Evaluation of deviations with regard to process and cleaning validation relevance Creation, maintenance and revision of submission documents, incl. answering inquiries from authorities regarding process and cleaning validation Representation of validation topics in audits and inspections Taking on the role of change manager with regard to change management if required

Your profile

Completed Master's degree in the natural sciences/technical field with several years of professional experience, alternatively Bachelor's degree or completed scientific training with many years of professional experience in the GMP environment (pharmaceuticals, biotechnology) or in the field of process and cleaning validation, preferably in the production of active ingredients Several years of experience in the biopharmaceutical/pharmaceutical/process engineering field Comprehensive GMP knowledge and knowledge of regulatory requirements Very good PC skills in the common MS Office applications Experience with SAP and/or TrackWise an advantage Fluent German and very good written and spoken English skills Very high degree of initiative, flexibility and sense of responsibility An independent, structured way of working and a high level of commitment Assertiveness, communication and teamwork skills, organizational skills and social competence High quality awareness and willingness to acquire an understanding of process technology

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