Job Description 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.
Requirements 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 Requirements Bachelor in Science