Process and Cleaning Validation Sme

vor 4 Monaten

Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

When you join us at Thermo Fisher Scientific, you’ll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

**_ Process and Cleaning Validation SME_**

In this function, you will part of the Manufacturing Science & Technology team in Lengnau, a state-of-the-art Drug Substance Manufacturing site for Biologic's. Reporting to the Head of Manufacturing Science & Technology, the Process and Cleaning Validation SME will contribute to the validation of Drug Substance processes in a multifaceted and dedicated team to enable commercial manufacturing in single use and stainless-steel suites.

**Key Responsibilities**:

- Acts as SME on Process and Cleaning Validation of Drug Substance for upstream and downstream area.
- Plan, perform, coordinates and report on Process and Cleaning Validation activities including Cleaning Validation, PPQ, CPV, E&L and supportive studies in conjunction with internal and external partners.
- Interact with peers in internal and external network, participate to global validation strategy definition and implementation, ensuring aligned approaches and knowledge exchange management.
- Represents Process and Cleaning Validation and Manufacturing Sciences in multi-functional teams (Quality, Engineering, etc.), including customer meetings.
- Supports CMC/regulatory filing documentation and Health Authority Inspection

**Education**
- Degree (Bachelor or Masters) in Life Sciences (Biology, Chemistry, etc.), Engineering Degree. or M.Sc. or B.Sc. or equivalent,

**Experience**
- Experience in Drug Substance GMP manufacturing (B.Sc.> 10yrs; M.Sc >8yrs) including overall knowledge in upstream and downstream process areas
- Experience in technical operation environment (>2 yrs)

**Knowledge, Skills, Abilities**
- Proficiency in working with multicultural and cross-disciplinary project teams
- Excellent organization, planning, problem solving and critical thinking skills
- Excellent writing, communication and presentation skills
- Energy and drive (committed, work towards results)
- Language: Fluency in English, German knowledge preferable

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, address complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

This job description does not describe all the duties, tasks and responsibilities which need to be performed in the Function. Any other job-related instructions, duties, tasks or responsibilities which are requested by the manager are required to follow.

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