Job Description:

·         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.

Job Requirements:

Minimum Qualification (education, experience and/or training, required certifications):

Education :

·         BSc. in Engineering, Bio/Pharmaceutical Technology, Chemistry, Microbiology or equivalent scientific degree.

·         Desirable MSc. or equivalent experience.

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.