Associate Validation Specialist

1 month ago

Toronto, Ontario, Canada Sotera Health Full time
Job Title: Associate Validation Engineer

Reporting to the Quality Assurance (QA) Manager or equivalent manager/supervisor, the Associate Validation Engineer will provide management with information and data on all key aspects of each customer's validation project, which is used by both the plant and the customer to determine the course of routine processing.

Key Responsibilities:
  • Plan, organize, and coordinate customer validation activities at the facility.
  • Write validation protocols and final reports supplied by the facility.
  • Review and approve customer or consultant supplied validation or test protocols for execution within the limitation of the facility's equipment and Sterigenics operating procedures and compliance with current regulatory standards.
  • Execute validation protocols and technically driven customer projects, which include but are not limited to the following: scheduling project runs, ancillary resources, lab testing, and sample handling.
  • Assure that all validation calibration activities are performed according to Sterigenics procedures and traceable to NIST.
  • Provide support to Maintenance or Engineering in the performance of IQ/OQ/PQ activities of new or existing facility equipment.
  • Responsible for annual equipment re-commissioning (sterilization and laboratory).
  • Update validation status in the relevant systems.
  • May be required to assist with corrective action and validation process improvement activities.
Requirements:
  • Minimum BA or BS in a science-related field (or international equivalent) and/or 4-6 years equivalent experience.
  • Two (2) to four (4) years experience in the pharmaceutical, food, or medical device industry with GMP/GLP knowledge a plus but not required.
  • Direct experience in sterility assurance or products sterilization a plus but not required.
  • Experience in writing and executing validation protocols preferred.
  • Customer service and project management experience desired.
  • ISO 9000 experience a plus.
  • Excellent written and verbal communication skills.
  • Strong computer skills.
  • Forklift driving experience preferred, however internal training will be given.
  • Must be able to lift a minimum of 50 lbs (23kg) and perform repetitive bending and lifting motions over a period of time.
  • Must be able to work a flexible schedule including weekends, holidays (if necessary).
  • Must be able to travel 10-20% to various locations as needed.
Special Requirements:
  • Must possess a thorough understanding of US FDA Quality Systems Regulations, ISO 9000 regulations, and international regulatory requirements.
  • Knowledge and experience working with the FDA and/or international requirements for medical devices is essential.
  • Knowledge of regulatory affairs for FDA (or international equivalent) registered medical device or pharmaceutical manufacturer and direct experience with conducting or participating in FDA (or international equivalent) or supplier audits.
  • Experience in document control to satisfy all ISO 9000 and FDA (or international equivalent) Quality System requirements.
  • Must be medically approved for respirator use (EO).
  • Must be able to tolerate exposure to high temperatures and high humidity [up to 130F (55C) and 65% RH for 20 minutes] (EO).
Training Required:
  • Must complete all required training for a "Quality Assurance Manager" outlined in the training program.

  • Associate Validation Specialist

    3 weeks ago

    Toronto, Ontario, Canada Sotera Health Full time

    Job SummaryWe are seeking a highly skilled and experienced Associate Validation Engineer to join our team at Sotera Health. As a key member of our Quality Assurance department, you will be responsible for providing management with information and data on all key aspects of each customer's validation project.Key ResponsibilitiesPlan, organize, and coordinate...

  • Computer System Validation Specialist

    1 month ago

    Toronto, Ontario, Canada Innomar Strategies Full time

    Job Title: Computer System Validation SpecialistAt Innomar Strategies, we are seeking a highly skilled Computer System Validation Specialist to join our team. As a key member of our validation team, you will be responsible for ensuring the compliance of our computerized systems with regulatory requirements.Key Responsibilities:Develop and implement computer...

  • Computer System Validation Specialist

    1 month ago

    Toronto, Ontario, Canada Innomar Strategies Full time

    Job Title: Computer System Validation SpecialistAt Innomar Strategies, we are seeking a highly skilled Computer System Validation Specialist to join our team. As a key member of our validation team, you will be responsible for ensuring the compliance of our computerized systems with regulatory requirements.Key Responsibilities:Develop and implement computer...

  • Model Validation Specialist

    1 month ago

    Toronto, Ontario, Canada BMO Full time

    About the RoleWe are seeking a highly skilled Model Validation Specialist to join our team at BMO. As a key member of our team, you will be responsible for validating models and assessing model risk to ensure their appropriateness and capability for a designated portfolio.Key ResponsibilitiesPerform validation of models and assess model risk to confirm model...

  • Model Validation Specialist

    1 month ago

    Toronto, Ontario, Canada BMO Full time

    About the RoleWe are seeking a highly skilled Model Validation Specialist to join our team at BMO. As a key member of our team, you will be responsible for validating models and assessing model risk to ensure their appropriateness and capability for a designated portfolio.Key ResponsibilitiesPerform validation of models and assess model risk to confirm model...

  • System Validation and Integration Specialist

    1 day ago

    Toronto, Ontario, Canada Alstom Full time

    At Alstom, we understand the complexity of transport networks and our role in shaping greener and smarter mobility worldwide. Our broad portfolio encompasses high-speed trains, metros, monorails, trams, turnkey systems, services, infrastructure, signalling, and digital mobility solutions.ObjectiveWe are seeking a highly skilled System Validation and...

  • IT Systems Validation Specialist

    7 days ago

    Toronto, Ontario, Canada Mpi Inc. Full time

    IT Systems Validation SpecialistKey Responsibilities:Develop project validation plans and generate summary reports to ensure compliance with regulatory requirements.Evaluate risk assessment and functional requirements specifications to identify potential issues.Act as liaison between quality assurance and project teams to facilitate effective...

  • Systems Validation Specialist

    2 months ago

    Toronto, Ontario, Canada Mpi Inc. Full time

    About Mpi Inc.Mpi Inc. is a leading provider of innovative solutions in the field of computer systems validation.Job SummaryWe are seeking a highly skilled Systems Validation Specialist to join our team. The ideal candidate will have a strong background in computer systems validation and excellent communication skills.Key ResponsibilitiesDevelop project...

  • Systems Validation Specialist

    2 months ago

    Toronto, Ontario, Canada Mpi Inc. Full time

    About Mpi Inc.Mpi Inc. is a leading provider of innovative solutions in the field of computer systems validation.Job SummaryWe are seeking a highly skilled Systems Validation Specialist to join our team. The ideal candidate will have a strong background in computer systems validation and excellent communication skills.Key ResponsibilitiesDevelop project...

  • Computer System Validation Specialist

    3 weeks ago

    Toronto, Ontario, Canada Innomar Strategies Full time

    Job SummaryWe are seeking a highly skilled Computer System Validation Specialist to join our team at Innomar Strategies. As a key member of our quality assurance team, you will be responsible for leading the validation of computerized systems and ensuring compliance with regulatory requirements.Key ResponsibilitiesDevelop and implement computer system...

  • Validation and Compliance Specialist

    1 week ago

    Toronto, Ontario, Canada Sotera Health Full time

    About the Role:We are seeking an experienced Associate Validation Engineer to join our team at Sotera Health. In this role, you will be responsible for providing management with information and data on all key aspects of each customer's validation project.Duties and Responsibilities:Plan, organize, and coordinate customer validation activities at the...

  • Senior Model Validation Specialist

    3 weeks ago

    Toronto, Ontario, Canada BMO Full time

    Job Summary:We are seeking a highly skilled Senior Model Validation Specialist to join our team at BMO. As a key member of our model validation program, you will be responsible for ensuring the accuracy and reliability of our models, as well as identifying and mitigating potential risks.Key Responsibilities:Validate models and assess model risk to confirm...

  • Senior Model Validation Specialist

    3 weeks ago

    Toronto, Ontario, Canada BMO Full time

    Job SummaryWe are seeking a highly skilled Senior Model Validation Specialist to join our team at BMO. As a key member of our risk management and analytics team, you will be responsible for validating models and assessing model risk to ensure their appropriateness and capability for designated portfolios.Key ResponsibilitiesValidate models and assess model...

  • Quantitative Model Validation Associate

    4 weeks ago

    Toronto, Ontario, Canada MUFG Full time

    Model Validation Quantitative Associate - Market RiskAre you passionate about ensuring the accuracy and reliability of financial models? Do you have a strong background in quantitative analysis and risk management? We're seeking a highly skilled Model Validation Quantitative Associate - Market Risk to join our team at MUFG.Key Responsibilities:Validate...

  • Quantitative Model Validation Associate

    4 weeks ago

    Toronto, Ontario, Canada MUFG Full time

    Model Validation Quantitative Associate - Market RiskAre you passionate about ensuring the accuracy and reliability of financial models? Do you have a strong background in quantitative analysis and risk management? We're seeking a highly skilled Model Validation Quantitative Associate - Market Risk to join our team at MUFG.Key Responsibilities:Validate...

  • Quantitative Model Validation Associate

    1 month ago

    Toronto, Ontario, Canada MUFG Full time

    Model Validation Quantitative Associate - Market RiskAre you passionate about ensuring the accuracy and reliability of financial models? Do you have a strong background in quantitative analysis and risk management? We're seeking a highly skilled Model Validation Quantitative Associate - Market Risk to join our team at MUFG.Key Responsibilities:Validate...

  • Quantitative Model Validation Associate

    1 month ago

    Toronto, Ontario, Canada MUFG Full time

    Model Validation Quantitative Associate - Market RiskAre you passionate about ensuring the accuracy and reliability of financial models? Do you have a strong background in quantitative analysis and risk management? We're seeking a highly skilled Model Validation Quantitative Associate - Market Risk to join our team at MUFG.Key Responsibilities:Validate...

  • Quantitative Model Validation Associate

    2 weeks ago

    Toronto, Ontario, Canada MUFG Full time

    Make a meaningful impact in the world of finance.Mitsubishi UFJ Financial Group (MUFG), the 7th largest financial group in the world, is seeking a skilled Quantitative Model Validation Associate - Market Risk to join our team.As a Quantitative Model Validation Associate - Market Risk, you will be responsible for ensuring the accuracy and reliability of our...

  • Model Validation Expert

    3 weeks ago

    Toronto, Ontario, Canada Intact Financial Corporation Full time

    At Intact Financial Corporation, we're seeking a highly skilled Model Validation Specialist to join our Risk Management team. As a key member of our team, you'll be responsible for leading the independent review, validation, and challenge of our Canadian internal economic capital model. This includes structuring and executing internal model validation and...

  • Risk Model Validation Associate

    7 days ago

    Toronto, Ontario, Canada MUFG Full time

    Make a meaningful impact in the world of finance.Mitsubishi UFJ Financial Group (MUFG) is a global leader in the financial industry, with 120,000 colleagues worldwide striving to make a difference for every client, organization, and community we serve.We're seeking a highly skilled Model Validation Quantitative Associate - Market Risk to join our team,...