Job Description Candidates, please review the following client requirement/duties for this role; • Working knowledge of pharmaceutical/biotech processes. • Familiarity with validation and documentation processes in a highly regulated environment. • Ability to operate specialized laboratory equipment and computers as appropriate. • 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 o Establish Testing Strategies o Design / Development of Characterization Protocols o Technical Reports Development o Validations, and technical reports- To support SATs executions, document generation and challenge validations strategies. o 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: o Basic technical report writing and Validation Protocol Writing o Verbal communication o Basic technical presentations o Personal Organization o Dealing with and managing change o Technical (Equipment Specific) o Analytical Problem Solving o Computer Literacy o Schedule development o Facilitation o Collaboration o Basic project management o 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: o Negotiation, persuasion and facilitation Collaboration o Project cost development o Conflict Resolution o Schedule and resources loading development • Flexibility to work off-hours Requirements Candidates must comply with years of experience and minimum education requirements as follows; Doctorate degree or Master's degree and 5 years of Scientific experience or Bachelor's degree and 6 years of Scientific experience
