MSAT Process and Validation Expert

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Job Description:

Acts as a guide on 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 & experience.

Your qualifications:

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.

What we offer:

You can expect a wide-ranging job in a dynamic and international environment. A culture in which you live integrity, intensity, involvement, and innovation. A well-founded induction and task-specific training are a matter of course for us, driven remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.

You yourself resolve your future in our company – make your contribution to joint success!

Interested?

Then apply online with the usual documents (up to a maximum of 2 MB).

As an employer, 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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