Validation Specialist

7 days ago


North Chicago, Illinois, United States Katalyst Healthcares and Life Sciences Full time
{"title": "Validation Engineer IV", "description": "Job Summary

Katalyst Healthcares and Life Sciences is seeking a highly skilled Validation Engineer IV to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the integrity of our client Quality System.

Responsibilities
  • Quality System Integrity: Maintain the integrity of the client Quality System, ensuring compliance with Medical and Nutritional Agency Regulations, ISO Standards, and Client Policies and Procedure.
  • Client Interface: Act as a single point-of-contact to interface with Client division customers, providing quality-related discipline expertise and consultation to direct and contingent project personnel.
  • Documentation and Validation: Develop and manage documentation for engineering studies (ES) and commissioning tests (CT), execute ES and CT activities, and develop and maintain the validation traceability matrix (VTM).
  • Data Analysis and Reporting: Provide data entry and statistical analysis of data collected during validation activities, and develop documentation for GMP criticality assessment and coordinate activities.
  • Validation Strategy and Execution: Interpret validation/user requirements, provide validation strategy in conjunction with division quality and operations organizations, develop and draft validation protocols, execute validations, and document validation results in final reports.
  • Good Documentation Practices: Ensure that validations are documented using Good Documentation Practices and in compliance with Medical and Nutritional Agency Regulations, ISO Standards, and Client Policies and Procedure.
  • Investigations and Risk Assessments: Perform and document investigations related to validation activities, and perform risk assessments of equipment and processes to support scope of validation.
  • Remediation and Compliance: Identify and propose remediation for existing and potential validation issues, provide technical expertise, and provide solutions to maintain compliance.
  • Technical Expertise: Provide quality-related discipline expertise to divisional customers, project teams, and consultation to direct and contingent project personnel.
  • Education and Experience: 5-10 years of related work experience in a medical device or other healthcare industry with strong technical competency in performing facility/utilities/equipment qualification, et al. validations, and a history of completing successful cross-functional projects and driving positive, compliance outcomes.
  • Skills and Qualifications: Strong validation experience in facilities, utilities, equipment, automated process controls, statistical sampling, and process monitoring, proficiency in Microsoft Word, Excel, and Outlook, and experience in temperature/humidity mapping studies and validation of facilities storage spaces and manufacturing rooms, as well as environmental equipment.
Requirements
  • Education: Bachelor's degree in a relevant field.
  • Experience: 5-10 years of related work experience in a medical device or other healthcare industry.
  • Skills: Strong technical competency in performing facility/utilities/equipment qualification, et al. validations, and proficiency in Microsoft Word, Excel, and Outlook.
What We Offer

Katalyst Healthcares and Life Sciences offers a competitive salary and benefits package, as well as opportunities for professional growth and development.

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