Skills: Chemical Engineering, Chemist, Engineering Manager
Experience: 6 + Years
Education: Bachelors/3-5 yr Degree
Employment Type: Full Time Contractor
Job Title: Senior Validation Engineer
Contract Length: 6 months
Start Date: July 2020
Salary: Hourly Rate (Market Competitive)
I have exciting opportunity here for those seeking an active leadership role in the Biotech industry. My client is one of the largest Biotech companies worldwide, with advanced innovations, technologies and processes. They are seeking out a Senior Validation Engineer to help out with a brand new project.
- Write and execute process validation protocols for new product. Write process validation reports after completion of the process validation study. Work together with cross functional teams and QA to define the validation requirements, draft the validation protocol, plan window for execution and conduct training for the execution. Perform data collection and compilation, interpret data and document results into the validation protocols.
- Perform material qualification for new raw materials and process aids used in the new process: write risk profiles, material qualification protocols and reports for chemical raw materials and process aids. Perform E&L (extractables and leachables) assessment and document the assessment in the E&L report.
- Support the team in other required activities for the implementation of the new process on site.
- Minimally a bachelor's degree in chemical engineering, biomedical sciences, bioengineering, biochemistry or chemistry with 6 years of relevant biological manufacturing experience. Have a good technical understanding of upstream and downstream biological processes.
- Experience in process validation and material qualification in a GMP environment or pharmaceutical industry. Have a good understanding of validation requirements for process validation for biological manufacturing.
- Independent worker, able to work collaboratively across different functions. Have the ability to coordinate activities within the cross functional teams for successful validation execution.
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