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Bioprocess Engineer in Biotech
1. Analyzes and solves problems in Production and Quality Control.
2. Develops manufacturing methods and processes. Ensures new manufacturing processes can be scaled-up to produce products within specifications.
3. Evaluates technologies for reliability, reproduction capability, consistency, and cost effectiveness.
4. Develops validation protocols for manufacturing equipment and processes. Ensures validation of equipment and processes, evaluates data and writes reports.
5. Develops test methods and protocols.
6. Establishes and characterizes special test reagents and reference standards.
7. Reviews and signs off on QC data that fails QC tests. Evaluates failures, writes Variance Reports (VR's), presents recommendations to Material Review Board.
8. Evaluates product history, recommends revisions to product specifications, originates Change Orders (CO's).
9. Interfaces with Product Development, Research, and Production to bring new technologies, methods, and tests into Manufacturing.
10. Trains Chemists in new processes and procedures.
11. Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management.
12. Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices.
Requires a minimum of a Bachelor's degree in biological sciences or related field
Requires a minimun of 8 years of hands on laboratory experience in a reagent process development or reagent manufacturing environment
A minimum of 1 year experience in a FDA or ISO regulated environment
A MS or PhD
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