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vor 6 Monaten
Lengnau, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, increasing productivity in their...
Process Validation Expert
vor 2 Monaten
As a Process Validation Expert - Upstream and Downstream Operations, you will play a key role in ensuring the quality and integrity of our drug substance manufacturing processes.
Key Responsibilities:- Act as a guide for Process and Cleaning Validation of Drug Substance for upstream and downstream areas.
- Establish and supervise validation KPIs.
- 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 global validation strategy definition and implementation, ensuring aligned approaches and knowledge exchange management.
- Work closely with other departments like Manufacturing, Engineering, Regulatory, and Quality to ensure Health Authority Inspection.
- Represent Process and Cleaning Validation and Manufacturing Sciences in multi-functional teams (Quality, Engineering, etc.), including customer meetings ensuring best customer service and experience.
- Degree (Bachelor or Masters) in Life Sciences (Biology, Chemistry, etc.), Engineering Degree, or equivalent.
- 8 years+ of Experience in Drug Substance GMP manufacturing, including sound knowledge in upstream and downstream process areas and related process equipment.
- Guide in analyzing and writing technical reports and presentations.
- Good Experience in 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.
- Language: Proficiency in English, German knowledge preferable.
