Cleaning Validation Coordinator

We Are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

Our Team, Your Impact

Cleaning Validation Specialist

12 month contract

Stouffville, Ontario

We are seeking a detail-oriented and motivated Cleaning Validation Specialist to join our team. In this role, you will support and execute cleaning validation activities to ensure compliance with cGMP requirements and global regulatory standards. You will collaborate with cross-functional teams, including Quality Assurance, Quality Control, Operations, Engineering, and MS&T, to maintain validated cleaning processes and support continuous improvement initiatives.

How You’ll Spend Your Day

• Assist in the preparation, execution, and reporting of cleaning validation studies.
• Coordinate and perform equipment swabbing and rinse sampling activities.
• Collect, review, and organize cleaning validation data.
• Evaluate cleaning validation results against established acceptance criteria.
• Support periodic reviews of the cleaning validation program.
• Prepare and revise validation protocols, reports, risk assessments, and related documentation.
• Ensure validation documentation complies with GMP requirements, company procedures, and applicable regulatory standards.
• Support investigations related to cleaning validation deviations, excursions, and out-of-trend results.
• Maintain validation records and ensure all documentation remains audit and inspection ready.
• Coordinate validation activities with QA, QC, Operations, Engineering, and MS&T teams.
• Schedule and manage cleaning validation activities to align with manufacturing operations.
• Participate in risk assessments, including FMEA, gap assessments, and other quality risk management activities.
• Support the identification of worst-case products, equipment trains, and sampling locations.
• Contribute to continuous improvement initiatives related to cleaning procedures and validation practices.
• Trend validation data to identify recurring issues and opportunities for process enhancement.
• Ensure compliance with cGMP, Health Canada, FDA, EMA, and internal quality system requirements.
• Participate in investigations, CAPAs, change controls, and regulatory inspection support activities.
• Perform other duties as assigned.

Your Skills and Experience

• Bachelor's degree in Science, Engineering, Pharmacy, or a related discipline.
• 1 to 3 years of relevant experience, preferably within the pharmaceutical, biotechnology, or regulated manufacturing industry.
• Knowledge of cleaning validation principles, GMP regulations, and pharmaceutical manufacturing processes is preferred.
• Understanding of Canadian, U.S., and European regulatory requirements, including GMP/GLP requirements, WHMIS, and workplace safety standards.
• Experience with validation documentation, investigations, CAPAs, and change controls is considered an asset.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and quality systems such as LIMS, Veeva, TrackWise, and Knowledge Tree.
• Strong organizational, time management, and multitasking skills with the ability to manage multiple priorities.
• Excellent communication, collaboration, and problem-solving skills.
• Ability to work effectively in a cross-functional and fast-paced environment.
• Willingness to