Validation Specialist

4 days ago

Lombard, United States bioMerieux Inc. Full time


Description

The Validation Specialist will develop, implement, and manage validation activities across multiple domains, including equipment, process, software, cleaning, environmental, and product validation. This role ensures that all validation activities comply with regulatory standards and internal procedures, minimizing risks while supporting operational excellence. The Validation Specialist will work closely with cross-functional teams, vendors, and regulatory bodies to execute validation initiatives aligned with the site‘s goals. Job Responsibilities: Validation Project Management:
  • Plan, coordinate, and execute validation projects independently, ensuring adherence to timelines and regulatory requirements.
  • Lead validation activities across various domains, such as equipment qualification (IQ/OQ/PQ), software validation, and process validation.
Risk Management and Compliance:
  • Utilize robust validation principles to ensure all activities meet cGMP, ISO 13485, and other relevant standards.
  • Conduct and lead risk assessments to identify potential issues, mitigate risks, and ensure continuous compliance.
  • Support change control processes, re-qualifications, and re-validations as part of continuous improvement efforts.
Documentation and Reporting:
  • Develop, review, and maintain comprehensive validation documentation, including protocols, reports, SOPs, and validation master plans.
  • Ensure documentation meets internal procedures and regulatory expectations, facilitating smooth audits and inspections.
  • Provide technical writing support to ensure accurate, detailed, and compliant documentation.
Collaboration with Internal and External Teams:
  • Collaborate with Quality, QC, Engineering, and Operations teams to align validation activities with project objectives.
  • Coordinate with suppliers and external vendors for equipment and system validations, ensuring alignment with site requirements.
Training and Knowledge Transfer:
  • Provide training to project teams and operators on new or revised validation processes and standards.
  • Stay updated on current industry trends, guidance documents, and regulatory changes to implement best practices.
Audit Support:
  • Participate in internal and external audits related to validation, addressing any non-conformities and implementing corrective actions.
  • Support the preparation for supplier audits by ensuring validation processes and documents are audit-ready.
Environmental and System Monitoring:
  • Monitor controlled environmental systems daily, maintain audit logs, and investigate any deviations or non-conformities.
  • Ensure that systems remain in a state of validation through regular monitoring and performance assessments.
Other Duties as Assigned:
  • Perform additional tasks as required, aligned with the role‘s scope and departmental needs.
Job Responsibilities
  • Bachelor‘s Degree required. BS in Engineering, Life Sciences, or a related field is preferred.
  • 2+ years of experience in a cGMP manufacturing environment, with a focus on validation.
  • Hands-on experience with equipment, process, software, or environmental validation.
  • Familiarity with regulatory requirements such as ISO 13485, FDA 21 CFR Part 11, and relevant GAMP guidelines.
Knowledge and Skills
  • Strong analytical, problem-solving, and project management skills.
  • Excellent technical writing and documentation abilities.
  • Proficiency in common validation software tools and an ability to learn new methodologies quickly.
  • Experience in risk assessment processes and the ability to lead cross-functional teams in mitigation efforts.
  • Strong communication skills to work effectively with cross-functional teams and external vendors.


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