Validation Engineer - Katalyst Healthcares & Life Sciences
Michigan, MI 49409
About the Job
Responsibilities:
- Validation Protocol Development: Develop and review validation protocols, including but not limited to Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV) protocols, ensuring alignment with regulatory requirements and company standards.
- Execution of Validation Studies: Execute validation studies according to approved protocols, including coordinating testing activities, collecting and analyzing data, and documenting results in compliance with regulatory standards and internal procedures.
- Data Analysis and Interpretation: Analyze validation data to assess the performance and compliance of systems, processes, and products. Identify deviations, trends, and areas for improvement, and propose corrective and preventive actions as necessary.
- Documentation and Reporting: Prepare comprehensive validation reports summarizing study objectives, methods, results, and conclusions.
- Ensure documentation is accurate, complete, and compliant with regulatory requirements and company standards.
- Cross-functional Collaboration: Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, Engineering, and Production, to ensure alignment on validation activities, share insights, and address issues or concerns related to validation.
- Continuous Improvement: Identify opportunities for process improvements in validation activities, methodologies, and documentation practices.
- Implement best practices to enhance the efficiency and effectiveness of validation processes.
- Regulatory Compliance: Stay updated on relevant regulatory requirements, guidelines, and industry standards related to validation.
- Ensure validation activities are conducted in compliance with applicable regulations, such as FDA, ISO, and other relevant regulatory bodies.
- Risk Assessment: Conduct risk assessments to identify potential hazards and risks associated with validation activities.
- Develop risk mitigation strategies and incorporate risk management principles into validation planning and execution.
- Bachelor's degree in engineering, Science, or related field. Advanced degree preferred.
- Previous experience in validation engineering or a related field, preferably in a regulated industry such as pharmaceuticals, medical devices, or biotechnology.
- Strong understanding of validation principles, methodologies, and regulatory requirements (e.g., FDA, ISO).
- Proficiency in data analysis tools and statistical techniques.
- Excellent documentation and report writing skills, with attention to detail.
- Ability to work effectively in a cross-functional team environment and communicate complex technical concepts to non-technical stakeholders.
- Strong problem-solving and critical thinking skills.
- Certifications such as Certified Validation Professional (CVP) or Certified Quality Engineer (CQE) are a plus.
Source : Katalyst Healthcares & Life Sciences