JOB DESCRIPTION – MANAGER STERALIZATION VALIDATION MAINTENANCE
- Plan, coordinate review, approve and manage the validation and re-validation personnel and activities to support Industrial Operations and R&D for Sterilization, Decontamination and Dehydrogenation processes for the Technical Services SVM Group.
- Provide scientifically sound analysis, discussions and recommendations where required for troubleshooting and investigative roles for all Quality Systems.
- Represent Sanofi Pasteur during Regulatory, Corporate or Internal inspections or activities.
- Manage sterilization re-validation & validation projects including:
- Design scientifically sound studies and prepare detailed validation protocols.
- Coordinate validation activities with a multidisciplinary team with both internal and external personnel as required
- Review of raw data for scientific and regulatory accuracy
- Prepare, review and or approve validation reports consistent with sanofi pasteur policies and acceptable to regulatory agencies. Ensure clarity and correct scientific content in discussions.
- Coordinate process improvement projects or studies. Perform validation or process improvement experiments or work with system/process owner to perform the validation as per designated protocols.
- Perform root cause analysis as part of investigations and working with the process owner and subject matter experts.
- Provide training for execution of protocols and process improvement studies to assist in successful completion of project. Support manufacturing in PC/APC implementation as required.
- Represent Technical Services SVM Group on capital projects
- Act as a delegate for the Deputy Director of Technical Services SVM Group for specified activities
CONTEXT OF THE JOB/MAJOR CHALLENGES:
- The majority of the job will be performed in an office environment
- There will be activities that will require entry into production or laboratory environment
- Full gowning may be required for entry into controlled areas as per site policies
- May work with pathogens (Polio, Tetanus, and Diphtheria); immunization and BCG clearance required.
- Global travel may be required
- Determine strategy for process improvement or validation study based time, cost effectiveness, quality and regulatory compliance, with approval of the manager.
- Monetary impact on business is indirect, the job function relates to regulatory compliance of production processes, continuous improvement and resolution of production issues.
- Purchasing authority for manager level per P&P
- Accountable for multiple projects within IO and R&D
- Ensure that safe working practices are followed within the office, production and lab areas
- MS (Science/Engineering) with 3 years or BS/BA (Science/Engineering) with 5 years related experience.
- The Candidate should possess the following skills:
- Working knowledge of Sterilizing and Decontamination unit operations
- A familiarity with Regulatory Requirements for the vaccine industry
- Excellent Written and Verbal communication skill Working knowledge of troubleshooting methodology
- Professional certification will be an asset