Perform and lead risk assessment exercises in support of Peptide process scale up & validation activities. • Collaborate with R&D to ensure successful Peptide product development and technical transfer to Manufacturing. • Coordinate Scale up & validation activities including, but not limited to, protocol training, execution by validation and other departments, data collection, deviation resolution, and CAPA initiation, in support of assigned validation projects. • Maintain knowledge and comprehensive understanding of peptide regulations and current interpretations affecting equipment, product, and process • Scale up & Validation representative on site project team and resource to other departments for Peptide product and process knowledge. • Develop specialized technology/unit operations knowledge and provide training to operations as content expert for manufacturing standard operating procedures (SOPs). • Perform troubleshooting and investigation on unexpected issues. Own equipment related deviations, CAPAs and changes. Lead or participate in investigations, problem-solving activities such as root cause analysis, FMEA, problem analysis and in development/implementation of countermeasure for quality, safety, environmental events. • Provide Peptide process technical expertise for requirements, design, selection, installation, qualification, operation, maintenance, and reliability of process equipment and facilities. • Perform and summarize improvement opportunities in technical reports, investigations, plant/lab trials, data analysis and process modelling. • Active participation and engagement in the meetings and activities of the assigned process team and safety/environmental sub teams. • Ensure process complies with current industry regulatory expectations, new regulations, and corporate policies and programs for Quality, Health and Safety & Environmental, Process Safety.
