Manager Cleaning Validation-70062669-33875
MANAGER CLEANING VALIDATION
Sanofi Pasteur Limited is looking for an enthusiastic and results driven individual to join our Manufacturing Technology team as Manager Cleaning Validation. Reporting to the Deputy Director PPI Process, this position is responsible for developing strategy, planning and executing activities related to cleaning process development, cleaning process validation, cleaning process improvement and implementation for NV and PPI projects. The position is related to compliance, efficacy, quality and safety. The incumbent will design, plan and execute experiments to demonstrate robustness, optimize processes, efficiency of cleaning processes with the goal of product quality and safety. This individual will also maintain the validated status of cleaning processes, perform routine verification studies, audit current cleaning processes and ensure compliance with cGMP, site/global quality guidelines and current industry standards.
Key responsibilities will include the following:
1. Manage and coordinate the Cleaning Validation Team, including technologist(s) and contractor(s). Coordinate activities with staff performing executions from Production and BRD/ARD . Train and mentor personnel.
2. Interact with cross functional teams in Production, BRD/ARD, Quality Operations and other internal and external groups (France and USA) to support process development, process improvement and validation.
3. Participate in NV, PPI, CPP and INF project teams, working groups and task forces (local and or global). Responsible for scientific and technical aspects of assigned projects and activities.
4. Design, plan and execute studies to demonstrate robustness, optimize processes, efficiency of cleaning processes with the goal of product quality and safety.
5. Generate validation protocols, risk assessments and supportive developmental studies for cleaning processes.
6. Generate reports for cleaning process validation, and technical reports for specific projects.
7. Support and comply with all Sanofi Pasteur health, safety and environmental policies, contribute toward meeting departmental/platform goals; and demonstrate progress in preventing or reducing injuries and/or illness.
Qualifications required include:
- Minimum Degree in Pharmaceutical or Biological Sciences or Chemical Engineering.
- Minimum of five (5) years of previous relevant experience, including at least three (3) years in manufacturing.
- Professional certification would be an advantage.
- An in-depth knowledge of technical areas specific to cleaning process is required (Cleaning Process Design and Development, Residues and Limits, Sampling and Markers, Analytical Methods).
- An in-depth knowledge of technical areas specific to manufacturing processes is required (Formulation, Protein Chemistry, Scale-up, Cell & Viral Culture, Adjuvants).
- Candidate should possess a familiarity with Regulatory Requirements, a working knowledge of Project Management , Statistical Process Control (SPC ) skills and Six Sigma methodology.
- Additional specific competencies required include: think strategically, lead teams, develop people, make decisions.
Qualified candidates may submit their on-line resume with cover letter to www.sanofipasteur.ca quoting reference Manager Cleaning Validation, reference #33875 (DS).
Sanofi Pasteur, the vaccine division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Sanofi Pasteur Limited, located in Toronto, is one of the company’s four major R&D and manufacturing sites. We are home to Sanofi Pasteur’s North American centre for Analytical and Bioprocess R&D. As well, we are the largest Canadian vaccine producer: each year, we manufacture 50 million doses of vaccine and distribute them to more than 90 countries around the world. This variety of activities offers employees diverse opportunities for personal and professional growth. Our company attracts some of the best minds in the business from across the globe. Our 1,200 employees give us their best and we offer the best in return.
Sanofi in Canada embraces diversity in the workplace and is committed to achieving employment equity. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome applications from women, members of visible minorities, Aboriginal peoples and persons with disabilities.
Thank you in advance for your interest. Only those candidates selected for interviews will be contacted.
Job : Engineering & Maintenance
Primary Location : Canada
Job Posting : May 28, 2014, 9:37:08 AM
Shift : Day Job
Job Type : Regular
Employee Status : Regular