Validation Services Laboratory Specialist
Job Description
[Biosafety]
1. Perform virus and mycoplasma sterility testing.
2. Manage testing records and documentation.
3. Prepare GMP documentation and manage reagents and laboratory operations.
Qualifications
* Bachelor's degree or higher.
* Required knowledge in microbiology and/or cell culture.
* Entry-level candidates and experienced professionals are both welcome.
* Ability to understand English documentation and communicate effectively in English.
Preferred Qualifications
* Experience in a GMP environment.
* Experience supporting inspections by regulatory authorities such as MFDS, U.S. FDA, or EMA.
[Molecular Assay]
1. Perform qPCR assays.
2. Conduct PCR design, including optimization of temperature, cycle conditions, and primer design.
3. Perform sequencing assays.
4. Support analytical method validation activities.
5. Prepare GMP documentation and manage reagents and laboratory operations.
Qualifications
* Bachelor's degree or higher.
* Up to 3 years of relevant experience.
* Ability to understand English documentation and communicate effectively in English.
Preferred Qualifications
* Experience supporting inspections by regulatory authorities such as MFDS, U.S. FDA, or EMA.
* Hands-on experience with PCR design and molecular biological analysis.
[Microorganism]
1. Perform testing related to manufacturing water systems, including WFI (Water for Injection).
2. Conduct endotoxin and microbial limit testing.
3. Analyze test results and prepare trend reports.
Qualifications
* Bachelor's degree or higher.
* Up to 3 years of relevant experience.
* Ability to understand English documentation and communicate effectively in English.
Preferred Qualifications
* Experience in environmental monitoring and sampling within a GMP manufacturing facility.
* Experience supporting inspections by regulatory authorities such as MFDS, U.S. FDA, or EMA.
* Experience in setting up a new GMP manufacturing facility and performing qualification activities.
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.
www.sartorius.com/careers