About this role
Job title: Validation Services Laboratory Specialist
About the Role Validation Services Laboratory Specialist will perform microbiological and physiochemical tests according to validated protocols. The role includes interpreting results, compiling and reviewing laboratory data, and submitting records for final approval, supporting technology transfer and troubleshooting.
What You'll Do
- Perform process setup and qualification activities.
- Manufacture and purify plasmid DNA (pDNA).
- Operate microbial cell culture and fermentation processes.
- Prepare GMP documentation and maintain batch production records.
- Support technology transfer and troubleshooting activities.
What We're Looking For
- Bachelor's degree or higher.
- Minimum 5 years of relevant experience.
- Ability to understand English documentation and communicate effectively in English.
Nice to Have
- Experience supporting inspections by regulatory authorities such as MFDS, U.S. FDA, and EMA.
- Experience in establishing new manufacturing facilities and performing qualification activities.
- Experience in microbial cell culture and pDNA manufacturing processes.
Compensation & Benefits
- Salary: Not disclosed in posting.
- Benefits: Not specified.