Senior Process and Cleaning Validation Scientist

Work Schedule

Environmental Conditions

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.

Senior Process and Cleaning Validation Scientist

Location: Lengnau (Bern) - Switzerland

In this function, you willbepart 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, theSenior Process and Cleaning Validation Scientistwill contribute to the validation of Drug Substance processesto enable commercial manufacturing in single use and stainless-steel suites.

Key Responsibilities:

• Acts as anExperton Process and Cleaning Validation of Drug Substance for upstream and downstream area.
• Establish and monitor validation KPIs
• Plan, perform, coordinates and report on Process and Cleaning Validation activities including Cleaning Validation, PPQ, CPV, E&L and encouraging studies incollaborationwith internal and external partners.
• Supportglobal validation strategy definition and implementation, ensuring aligned approaches and knowledge exchange management
• Work closely with other departments like Manufacturing, Engineering, Regulatory and Quality to ensureHealth Authority Inspection
• Represent Process and Cleaning Validation and Manufacturing Sciences in multi-functional teams (Quality, Engineering, etc.), including customer meetingsensuring best customer service & experience

Education, Experience

• 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 areasand related process equipment.
• Expert in analyzing and writing technical reports and presentations.
• Good Experience in technical operation/manufacturingenvironment

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Knowledge, Skills, Abilities

• Proficiency in working with multicultural and cross-disciplinary project teams
• Excellentplanning, problem solving and critical thinking skills
• Excellent writing, communication and presentation skills
• Language: Proficiency in English, German knowledge preferable

We offer driven remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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