Process Development Scientist
hace 3 semanas
Process Development Scientist with working knowledge of pharmaceutical/biotech processes.
Duties:
- Validation and documentation processes in a highly regulated environment.
- Operate specialized laboratory equipment and computers as appropriate.
- Interpret and apply GLPs and GMPs.
- Apply a science-based approach to production.
- Development and Execution of Processes/Equipment Characterization
- Establish Testing Strategies
- Design / Development of Characterization Protocols
- Technical Reports Development
- Validations, and technical reports to support SATs executions, document generation and challenge validations strategies.
- Risk assessments and QRAES knowledge, to support risk assessments activities.
- Develop solutions to routine technical problems of limited scope.
- Comprehensive understanding of validation protocol execution requirements. In-depth knowledge of validation processes as applied to new equipment installations.
Qualifications
- Doctorate degree or Master's degree and 5 years of Scientific experience or
- Bachelor's degree and 6 years of Scientific experience
Basic technical report writing and Validation Protocol Writing - Verbal communication
- Basic technical presentations
- Personal Organization
- Dealing with and managing change
- Technical (Equipment Specific)
- Analytical Problem Solving
- Completion and follow-up
- Computer Literacy
- Schedule development
- Facilitation
- Collaboration
- Bilingual (Spanish/English)
- Flexibility to work off-hours
Additional Information
All your information will be kept confidential according to EEO guidelines.
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