Process Development Scientist
hace 3 semanas
Process Development Scientist with working knowledge of pharmaceutical/biotech processes.
Experience in:
- Validation and documentation processes in a highly regulated environment.
- Interpret and apply GLPs and GMPs.
- Ability to apply a science-based approach to production.
- Vision system technologies (strong knowledge).
- Inspection/packaging Concepts.
- 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.
- Able to 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
- Basic technical presentations
- Dealing with and managing change
- Analytical Problem Solving
- Computer Literacy
- Schedule development
- Facilitation/Collaboration
- Basic project management
- Completion and follow-up
- Specialized equipment/process expertise
- Interacts effectively with a variety of communication and working styles
- Ability to handle multiple projects at one time
- Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
- Problem solving skills for the application of scientific and engineering theory
- Skills in the development of hypotheses and approach
- Working knowledge of financial analysis tools
- Ability to delegate and manage the project work of others
- Bilingual (Spanish/English)(Write/Speak)
Skills in the following areas:
- Negotiation, persuasion and facilitation Collaboration
- Project cost development
- Conflict Resolution
- Schedule and resources loading development
- Flexibility to work off-hours
Additional Information
All your information will be kept confidential according to EEO guidelines.
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