Sanofi Group B100 IV / CSV / PQ Execution Lead - Vaccines in Toronto, Ontario
Reference No. R2588933
Position Title: B100 IV / CSV / PQ Execution Lead - Vaccines (Temporary - Full Time)
Department : C&Q Methods
Location: Sanofi Pasteur Limited, Toronto, Ontario
Sanofi Pasteur: The world’s leading vaccine company
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Summary of Purpose:
The Incumbent will ensure Installation Verification (IV), Computer System Validation (CSV) and Performance Qualification (PQ) executions of a strategic capital project at the Toronto site are completed meeting defined timelines. The project includes about 500 utility, facility and process/lab equipment systems. This position, augmented within the larger CQV document preparation / CQ Methods team, will be responsible for the timely completion of all deliverable associated with the IV, CSV and PQ executions.
Drive and deliver expected outcomes of IV, CSV and PQ executions meeting scheduled timelines.
IV execution include:
Leading a team of CQ consultants to execute IV test scripts.
Coordinating with the engineering team to resolve all gaps observed during the review of Vendor and Construction Turnover Documentation package reviews.
Working with engineering and CQV field execution teams to ensure IV test scripts required to be executed in the field are executed.
Coordinating with engineering, CQ and Quality teams to ensure all open items impacting IV executions are closed in advance of the executions.
- CSV execution include:
Ensuring review and approval of CSV test scripts are completed.
Coordinating with Automation SMEs to ensure CSV test scripts are executed.
- PQ execution include:
Ensuring Clean Utilities (Clean Compressed Air, Purified Water, Clean Steam and Water for Injection) PQ protocols are executed.
Results are complied and data package submitted for quality audit.
Ensure all executed IV, CSV and PQ test scripts/protocols are post-reviewed, comments are resolved and post-approved.
Be proactive and remove all roadblocks that could hold up executions.
Maintain CQ dashboards current indicating accurate executions statues of test scripts/protocols.
Ensure all assigned activities are always performed strictly following the established safety procedures and practices.
Other CQV support activities as deemed necessary by the CQ Manger.
Education and Experience:
Bachelor’s degree in engineering/science
3+ years of writing and executing commissioning and qualification protocols in pharmaceutical/bio-tech industry
Demonstrated project management skills
Ability to work independently and in teams
Sound written and verbal communications skills
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
Sanofi, Empowering Life
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.