Validation Expert

vor 10 Stunden

Biberach an der Riß, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

At GULP – experts united, we are currently seeking a skilled Validation Expert to join our team in the pharmaceutical industry. As a key member of our team, you will be responsible for supporting products in the context of process and cleaning validation, including representation in interdisciplinary project teams, compliance, and customer meetings.

Your Key Responsibilities:

  • Assume independent responsibility for the support of products in the context of process and cleaning validation, including representation in interdisciplinary project teams, compliance, and customer meetings.
  • Coordinate validation activities and plan process and cleaning validations, including the creation, maintenance, or revision of validation documents.
  • Conduct independent research and GMP-compliant evaluation of analytical and operational results and data.
  • Collaborate on control strategy, risk analysis, and other documents in cooperation with the development unit, production, analytical units, or other relevant interfaces.
  • Evaluate changes in manufacturing/cleaning processes of products with regard to process and cleaning validation relevance.
  • Evaluate deviations with regard to process and cleaning validation relevance.
  • Represent validation topics in audits and inspections.

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.
  • 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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