Charlottetown, Prince Edward Island
· Owner of the process and cleaning validation programs at the Elanco Canada Ltd. site.
· Ensure that products and processes are maintained in a continuous validated state, providing technical leadership and working directly with process teams to ensure accurate execution.
· Maintain the site validation master plan and schedule, ensuring on-time execution of validation activities.
· Work with manufacturing and quality teams to define and execute technical protocols, development activities, and technology transfer programs.
· Participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events.
· Prepare and provide critical review of validation documents, PFDs, batch records, SOPs, technical protocols, and reports.
· Provide the necessary support in internal and external audits.
· Train and develop validation support staff, and enhance the level of validation knowledge at the site.
· Demonstrate strict adherence to cGMP standards and Elanco policies and procedures.
· Maintain “Safety First and Quality Always” mindset.
Minimum Qualification (education, experience and/or training, required certifications):
· BSc. in Engineering, Bio/Pharmaceutical Technology, Chemistry, Microbiology or equivalent scientific degree.
· Desirable MSc. or equivalent experience.
· Minimum 3-5 years’ validation experience in the pharma/biotech industry, with emphasis on process and cleaning validation
· Proven understanding of biopharmaceutical production processes.
· Broad knowledge of pharma/biotech validation, regulatory compliance, cGMP standards, and applicable international guidelines and regulations.
· Demonstrated knowledge and experience in the practical and theoretical requirements of validation in a commercial cGMP manufacturing facility.
· Proven success in leading multi-disciplinary project teams with excellent communication, problem-solving, and critical-thinking skills.
Key Performance Indicators:
· Validation RFT.
· Number of Deviations/OOS/OOE.
· Effectiveness of CAPAs.
· Success rate of internal audits and Health Authorities' inspections.