Manager Sterilization Validation Maintenance

JOB DESCRIPTION – MANAGER STERALIZATION VALIDATION MAINTENANCE

RESPONSIBILITIES:

  • 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

DIMENSIONS/SCOPE:

  • 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

REQUIREMENTS:

  • 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

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