November 4, 2024

Professional Pharma Solutions

Juncos

CONTRACT & FULL TIME

Process Development Scientist

To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Conceives and designs, executes or evaluates, and interprets experimental strategies.
Duties/Responsibilities:

Working knowledge of pharmaceutical/biotech processes.
Familiarity with validation and documentation processes in a highly regulated environment.
Ability to interpret and apply GLPs and GMPs.
Ability to apply science based approach to production.
Strong Knowledge on Vision system technologies
Inspection/packaging Concepts Knowledge
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.

Demonstrated skills in the following areas:

- 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
- Computer Literacy
- Schedule development
- Facilitation
- Collaboration
- Basic project management
- Completion and follow-up

Specialized equipment/process expertise.
Interacts effectively with 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.
Skills in the following areas: