Validation Manager

Get started now as a pharmacist with Randstad professional solutions Our friendly colleagues in Biberach also have the right position for you. We are currently looking for a Validation Expert on behalf of our business partner in the pharmaceutical industry . Apply today and start your new job tomorrow We actively embrace diversity, which is why we welcome all applications.

Here's what we offer

Attractive salary package with Christmas and vacation bonuses Reimbursement of travel expenses Up to 30 days vacation per year Development of skills Open corporate culture

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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