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Job Description
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. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed 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.
Senior Scientist QM Validation
Location: Lengnau
As a Senior Scientist QM Validation, you are part of the Quality Management team at our new Lengnau facility. Your core responsibility lies in the compliance checks for validation documents and Master Batch records.
During ramp up of the facility, the role plays a key part in ensuring Quality oversight of validation activities and provide QA support and mentorship to related functional departments.
Your responsibilities
- Ensure compliance to Quality Standards and Validation Master Plans for Cleaning- and Manufacturing Processes working closely with MSAT, QC, Manufacturing and Engineering teams.
- Actively assess change and deviations associated to cleaning and process validation as well as analytical method validation.
- Ensure that electronic Master Batch Records are established and in line with Validation Reports and are compliant to internal standards and to cGMP regulatory expectations.
- Improve continuously quality standards for assigned areas of responsibilities.
- Actively support regulatory inspections as well as customer audits.
Your qualification:
- Degree (Bachelor or Masters) in Life Sciences (Biology, Chemistry, etc.) or Engineering, Dipl. lng. or M.Sc. or B.Sc. or equivalent.
- Experience (minimum 3 years) preferably gained on a Life Sciences / Pharma / Biotech (Upstream / Downstream / Fill Finish) manufacturing facility.
- Knowledge in chemical, biotech, or pharmaceutical manufacturing process as well as fundamental knowledge in the basics of cleaning and/or process validation.
- Basic Understanding of cGMP, GLP & cGxP practices
- Experience (2 years minimum) in one of the relevant areas: Master Batch record review in an electronic Manufacturing Execution System (MES), Validation of Cleaning and / or Manufacturing Processes and / or Analytical Methods.
- Proficient communication (oral and written) in English and German.
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. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, tackle sophisticated scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
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.
Agency note!
Please note that we are not interested in commercial placement offers from personnel service providers. If you decide to send us unsolicited application documents or to upload them, they will not be considered and will be deleted in accordance with our data protection guidelines
