Process Validation Scientist II
101 International Drive Portsmouth, NH 03801 US
- This individual is responsible for execution of Module E (GROUP-11246) Process Validation (PV) studies or associated PV support with intensive supervisory direction.
- The individual performs assigned duties according to specified procedures and receives detailed instructions.
- The individual performs a variety of routine work within established policies and procedures, and receives detailed instructions on new projects and assignments.
- Able to work with intensive assistance and supervision on 1 to 3 types of module tasks concurrently.
- The individual is expected to be a subject matter expert for routine assignments and it is expected that questions on tasks or issues will be raised by this individual when clarification or greater technical expertise is required.
- Protocol Generation, Execution, and Reporting (Analysis) Able to work with intensive assistance and supervision on basic PV techniques of protocol development, execution, and reporting to ensure technical content is sufficient and accurate.
- This individual is expected to ask questions about content.
- Not approved to make protocol decisions (i.e. conclusions, product impact / validation impact assessment, corrective actions) without review of a higher level PV scientist or Manager.
- With assistance and prompting, understands the role of specifications, acceptance criteria, and sample plans within PV protocols.
- Basic knowledge of discipline including standard industry guidance as well as the purpose of the Validation exercise.
- Note: Module E (GROUP-11246) includes, but is not limited to, the following PV Activities: PVMP Generation, PPQ Protocols, Large Scale Resin Re-Use, UF Membrane Lifetime, Mixing Validation, Bioburden/Endotoxin Control, Media Pre-Filtration, Impurity Clearance, Intermediate Process Hold, Reprocessing Protocols, Chromatography Mock Runs, BPC Hold Studies.
- Bachelor of Science Degree in Chemical Engineering, Mechanical, Biology, Biochemistry are preferred. Other life science degrees are acceptable.
- Experience: 0-3 years of biotech experience in process validation, process development or manufacturing
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