MSAT Process and Validation Expert

vor 1 Monat

Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Vollzeit

Job Summary:

We are seeking a highly skilled MSAT Process and Validation Expert to join our team at Thermo Fisher Scientific. As a key member of our Process and Cleaning Validation team, you will be responsible for guiding the validation of drug substance processes for upstream and downstream areas.

Key Responsibilities:

  • Establish and supervise validation KPIs to ensure the highest quality standards.
  • Plan, perform, coordinate, and report on Process and Cleaning Validation activities, including Cleaning Validation, PPQ, CPV, E&L, and encouraging studies in collaboration with internal and external partners.
  • Support the development of a global validation strategy and ensure its implementation, promoting aligned approaches and knowledge exchange management.
  • Work closely with other departments, such as Manufacturing, Engineering, Regulatory, and Quality, to ensure Health Authority Inspection readiness.
  • Represent Process and Cleaning Validation and Manufacturing Sciences in multi-functional teams, including customer meetings to ensure best customer service and experience.

Requirements:

  • Bachelor's or Master's degree in Life Sciences (Biology, Chemistry, etc.) or equivalent.
  • At least 8 years of experience in Drug Substance GMP manufacturing, including sound knowledge in upstream and downstream process areas and related process equipment.
  • Excellent analytical and writing skills, with the ability to guide technical reports and presentations.
  • Good experience in a technical operation/manufacturing environment.
  • Proficiency in working with multicultural and cross-disciplinary project teams.
  • Excellent planning, problem-solving, and critical thinking skills.
  • Excellent writing, communication, and presentation skills.
  • Proficiency in English; German knowledge is preferable.

What We Offer:

At Thermo Fisher Scientific, we offer a dynamic and international work environment, where you can live our values of integrity, intensity, involvement, and innovation. We provide well-founded induction and task-specific training, driven remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits.

We encourage you to take ownership of your career and contribute to our joint success.

Apply Online:

Please submit your application with the usual documents (up to a maximum of 2 MB) through our online portal.

Thermo Fisher Scientific is committed to equal opportunity and cultural minority support and does not discriminate based on ethnic origin, color, religion, gender, sexual orientation, gender identity, national origin, disability, or legally protected status.

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