MSAT Process and Validation Expert

vor 2 Monaten

Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Vollzeit

Work Schedule

Other

Environmental Conditions

Office

Job Description

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 meaningful contributions to the world.

The state-of-the-art multi-purpose manufacturing facility is designed for large-scale production of biologics and has high expansion potential. Our site in Lengnau will offer highly flexible biomanufacturing technologies, from development to large-scale production including stainless steel equipment to meet our customer needs.

MSAT Process and Validation Expert

Location: Lengnau (Bern) - Switzerland

In this function, you will be part of the Manufacturing Science & Technology team in Lengnau, a state-of-the-art Drug Substance Manufacturing site for Biologic's.

Your Responsibilities:

  • Acts as a guide on Process and Cleaning Validation of Drug Substance for upstream and downstream area.
  • Establish and supervise validation KPIs
  • Plan, perform, coordinates 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 M.Sc. or B.Sc. 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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