MSAT Process and Validation Expert

vor 4 Wochen

Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Vollzeit
Job Title: MSAT Process and Validation Expert

Thermo Fisher Scientific is seeking a highly skilled MSAT Process and Validation Expert to join our team. As a key member of our organization, you will be responsible for ensuring the quality and integrity of our drug substance manufacturing processes.

Key Responsibilities:
  • Develop and implement process validation strategies for upstream and downstream areas.
  • Establish and supervise validation KPIs to ensure compliance with regulatory requirements.
  • Plan, perform, and coordinate process validation activities, including cleaning validation, PPQ, CPV, E&L, and encouraging studies in collaboration with internal and external partners.
  • Support the development of global validation strategies and ensure aligned approaches and knowledge exchange management.
  • Collaborate 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 technical operation/manufacturing environments.
  • 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:

As a MSAT Process and Validation Expert at Thermo Fisher Scientific, you can expect a wide-ranging job in a dynamic and international environment. Our company culture is built on integrity, intensity, involvement, and innovation. We offer a 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 make a meaningful contribution to our joint success.

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