Provide front-line support for process improvement, validation, and tech transfer projects in compliance with cGMPs, SOPs and applicable guidelines and standards.
Functions, Duties, Task: • Support the execution of qualification, validation, and continued process verification projects (with a primary focus on process and cleaning validation), working directly with process teams on the shop floor to ensure accurate execution.Participate in equipment qualification and validation. • Work with manufacturing and quality teams in execution of technical protocols, development activities, and technical transfer programs. • Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are operating in a state of control, and identify opportunities for process improvements. • Participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events. • Assist in preparation and critical review of validation documents, PFDs, batch records, SOPs, technical protocols and reports.Provide the necessary support in internal and external audits. • Demonstrate strict adherence to cGMP standards and Elanco policies and procedures. Maintain “Safety First and Quality Always” mindset.
• BSc in Microbiology, Chemistry, Bio/Pharmaceutical Technology or equivalent scientific degree. • Minimum 2+ years experience in cGMP manufacturing and/or quality role(s). • Proven understanding of biopharmaceutical production processes and cGMP guidelines. • Strong oral and written communication skills.
• Desirable: MSc in Microbiology, Chemistry, Bio/Pharmaceutical Technology or related field. • Fundamental understanding of vaccine/biotechnology production processes. • Process/analytical development experience a plus.