Senior Scientist QM Qualification

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 more than 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.

The state-of-the-art multi-purpose manufacturing facility is crafted for large-scale production of biologics and has high expansion potential. After completion of construction activities, 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.

We are seeking a highly qualified Senior Scientist Quality Assurance Qualification to join our diverse team in Lengnau. As a global leader in scientific research and innovation, we are dedicated to enabling our customers to make the world healthier, cleaner, and safer. We are looking for a daring individual with confirmed experience in Pharma manufacturing site and 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 cGMP regulatory expectations during qualification activities.
• Document qualification activities in accordance with GMP standards.
• Assess and lead issues related to qualification, working closely with Manufacturing, QC, Engineering, and other relevant departments.
• Continuously improve quality standards for assigned quality systems and manufacturing areas.
• Prepare and approve quality systems-related documentation, ensuring compliant manufacturing of pharmaceutical products.
• Support internal and external inspections and drive the closure of identified gaps.
• Further 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 Pharma manufacturing site.
• 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 Language: Proficiency in English, German knowledge preferable

We offer a multifaceted 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. You yourself resolve your future in our company – make your contribution to joint success!

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.