Senior Scientist QM Qualification (M&W)

Join Our Team at Thermo Fisher Scientific

Thermo 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. Our global team of over 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience, and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

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

Position Overview: Senior Scientist Quality Assurance Qualification

We are seeking a highly qualified Senior Scientist in Quality Assurance Qualification to join our diverse team in Lengnau. As a global leader in scientific research and innovation, we are looking for a daring individual with confirmed experience in Pharma manufacturing, along with a strong background in Engineering or Life Sciences.

Key Responsibilities:

• Work closely with cross-functional teams to oversee GMP aspects of qualification activities, ensuring the delivery of outstanding facilities, utilities, and equipment.
• Ensure compliance with current Good Manufacturing Practice (cGMP) regulatory expectations during qualification activities.
• Document qualification activities in accordance with GMP standards.
• Assess and lead issues related to qualification, collaborating closely with Manufacturing, Quality Control, Engineering, and other relevant departments.
• Continuously improve quality standards for assigned quality systems and manufacturing areas.
• Prepare and approve quality systems-related documentation, ensuring compliance in the manufacturing of pharmaceutical products.
• Support internal and external inspections and drive the resolution of identified gaps.
• Promote active knowledge management and drive continuous improvement processes within the department.

Your Qualifications:

• Bachelor's or Master's degree in Engineering or Life Sciences (Biology, Chemistry, etc.), or equivalent.
• Experience in a Pharma manufacturing site.
• Proficiency in working with multicultural and cross-disciplinary project teams.
• Excellent organizational, planning, problem-solving, and critical thinking skills.
• Strong writing, communication, and presentation skills.
• Language: Proficiency in English; knowledge of German is preferable.

Why Join Us?

We offer a multifaceted job in a dynamic and international environment. Our culture prioritizes integrity, intensity, involvement, and innovation. Comprehensive induction and task-specific training are integral to our approach. Shape your future within our company and contribute to our collective success!

As an employer, Thermo Fisher Scientific is committed to equal opportunity and supports cultural diversity. We do not discriminate based on ethnic origin, color, religion, gender, sexual orientation, gender identity, national origin, disability, or legally protected status.

Apply online using the form below. Please note that only applications matching the job profile will be considered.