Validation Specialist IV

5 days ago

North Chicago, Illinois, United States Katalyst Healthcares and Life Sciences Full time
Job Summary

Katalyst Healthcares and Life Sciences is seeking a highly skilled Validation Specialist 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's Quality System.

Responsibilities
  • Maintaining Quality System Integrity: Develop and implement strategies to maintain the integrity of our client's Quality System, ensuring compliance with regulatory requirements and industry standards.
  • Client Interface: Serve as a single point-of-contact to interface with client division customers, providing technical expertise and support to ensure seamless collaboration.
  • Documentation and Execution: Develop and manage documentation for engineering studies (ES) and commissioning tests (CT), execute ES and CT activities, and ensure accurate documentation of results.
  • Validation Traceability Matrix: Develop and maintain the validation traceability matrix (VTM), ensuring accurate tracking of validation activities and results.
  • Data Analysis and Reporting: Provide data entry and statistical analysis of data collected during validation activities, and develop reports to communicate results to stakeholders.
  • GMP Criticality Assessment: Develop documentation for GMP criticality assessment and coordinate activities to ensure compliance with regulatory requirements.
  • Validation Strategy and Execution: Interpret validation/user requirements, develop and draft validation protocols, execute validations, and document 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.
  • Quality-Related Discipline Expertise: Provide quality-related discipline expertise to divisional customers, project teams, and consultation to direct and contingent project personnel.
  • Additional Responsibilities: Perform other duties as assigned by Management, and contribute to the development of quality-related processes and procedures.
  • Requirements: 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.
  • Technical Competencies: Must be familiar with good documentation practices (GDP) and cGMP environment, and have strong validation experience in the following areas: Facilities (Clean rooms, HVAC/Environmental Monitoring Program), Utilities (Water Systems), Equipment (Washers, Autoclaves and Fillers), Automated Process Controls, Statistical Sampling and Process Monitoring (SPC).
  • Education and Certifications: Bachelor's degree in a relevant field, and relevant certifications or training in validation and quality assurance.
  • Software Skills: Proficient using Microsoft Word, Excel, and Outlook for reporting and email correspondence.
  • Additional Requirements: Experience in temperature/humidity mapping studies and validation of facilities storage spaces and manufacturing rooms, as well as environmental equipment (e.g., Freezers, Refrigerators, Humidity Chambers, Incubators, etc.), and experience with troubleshooting and commissioning of commercial and/or industrial refrigeration systems, HVAC units, utilities distribution and controls (multiple platforms is a plus).

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