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.
Additional Skills / Preferences
Desirable : MSc in Microbiology, Chemistry, Bio / Pharmaceutical Technology or related field.
Fundamental understanding of vaccine / biotechnology production processes.
Process / analytical development experience a plus.