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Position Description: The Validation Specialist ensures products and processes are maintained in a validated state, compliant with regulatory and cGMP requirements, throughout their lifecycle. Provides leadership for all process and cleaning validation related activities, and is responsible for continuing to build the level of validation knowledge across the site.
Functions, Duties, Task:
- 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.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status