Validation Engineer - Katalyst Healthcares & Life Sciences
Los Angeles, CA 90001
About the Job
Responsibilities:
- Develop and execute validation protocols and reports for equipment and processes.
- Perform risk assessments and impact analyses for validation activities.
- Ensure compliance with regulatory requirements and industry standards.
- Conduct validation testing, including installation, operational, and performance qualification.
- Collaborate with cross-functional teams to identify and resolve validation issues.
- Review and approve validation documentation and change control requests.
- Participate in the development and improvement of validation procedures and best practices.
- Provide technical support for validation-related activities.
- Conduct training on validation procedures and requirements for relevant staff.
- Perform periodic reviews and revalidation of processes and systems.
- Investigate and resolve validation discrepancies and non-conformances.
- Conduct validation assessments for new equipment and process modifications.
- Stay updated on industry trends and regulatory changes related to validation.
- Conduct validation audits and prepare for regulatory agency inspections.
- Bachelor's degree in engineering, Computer Science, or a related field.
- Proven experience in validation and testing in a regulated industry.
- Thorough understanding of regulatory requirements, such as FDA, ISO, and GMP.
- Proficiency in documentation and record-keeping for validation activities.
- Strong analytical and problem-solving skills.
- Excellent communication and collaboration abilities.
- Knowledge of quality assurance principles and practices.
- Experience with statistical analysis and validation software/tools.
- Ability to manage multiple projects and prioritize tasks effectively.
- Detail-oriented with a focus on accuracy and compliance.
- Ability to work effectively in a fast-paced and dynamic environment.
- Certification in validation or quality-related disciplines is a plus.
- Experience with validation of manufacturing processes is highly desirable.
- Knowledge of risk management principles and methodologies.
- Understanding of validation lifecycle and methodologies.
Source : Katalyst Healthcares & Life Sciences