Validation Lab Technician
A leading biotechnology company is advertising a vacancy for a Validation Lab Technician. The organisation offers cutting-edge products and services for the development, quality assurance, and production processes of the biopharmaceutical industry, covering fermentation, cell cultivation, filtration, purification, fluid management, and lab technologies. Based in Shanghai, this position is an exciting opportunity to work with an innovative and prestigious organisation that is strongly rooted in the scientific community.
- Provide qualification/validation/quality/compliance support.
- Comply with laboratory safety procedures and requirements.
- Perform Viability, Bacterial Challenge, Product Specific Integrity, and Chemical Compatibility tests according to SOPs and approved validation protocols.
- Perform incoming material testing.
- Prepare strains, culture media, test solutions, and reagents necessary for the performance of all laboratory tests.
- Handle Biological Indicators, cultures, chemicals, and test solutions according to government regulations and company SOPs.
- Retrieve the corresponding test template from the system and fill accordingly.
- Complete lab data forms, interpret results, and review.
- Inform lab manager of any deviations related to validation protocol execution.
- Initiate and complete any investigations related to the deviation of validation protocols or out of specification results.
- Perform necessary cleaning and sanitizing of the lab and equipment after testing to keep the lab tidy.
- Check and monitor data of lab environment and temperature-controlled equipment on a daily basis.
- Perform inventory control of consumables and standard reagents to ensure the safety stock.
- Perform qualification, calibration, and maintenance of relevant equipment or device.
- Assist project management (feasibility check of validation studies).
- Review validation protocols and validation reports.
- Assist in the maintenance of Standard Operating Procedures, including writing and revising.
- Carry out any other tasks assigned by lab manager.
Skills and Requirements:
- Bachelor's degree in Sciences/Engineering, or Technical Science/Technological degree.
- 3-5 years' work experience, including filtration knowledge.
- Experience in the pharmaceutical industry is a plus.
- Good understanding of GMP requirements.
- Familiar with microbiological analysis testing and operating related equipment.
- Demonstrable oral and written communication skills - fluent in both Chinese and English.
- Must be willing and able to travel internationally for extended periods.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Lily Zhao at +86 21 51694106 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.