Process/Validation Engineer
- Employer
- Katalyst Healthcares and Life Sciences
- Location
- Durham, NC
- Closing date
- Oct 5, 2024
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- Sector
- Science, Physical Sciences and Engineering
- Organization Type
- Corporate
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Responsibilities:
- Validation Planning: Develop and implement validation strategies, including process, equipment, and cleaning validation, in compliance with FDA and international regulatory guidelines.
- Validation Protocol Design: Create and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and cleaning procedures.
- Process Optimization: Continuously improve manufacturing processes to enhance efficiency, reduce costs, and ensure product quality.
- Risk Assessment: Conduct risk assessments and develop risk mitigation strategies for manufacturing processes.
- Documentation: Maintain accurate and comprehensive validation documentation, including validation master plans, validation reports, and change control documents.
- Regulatory Compliance: Ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations and guidelines.
- Collaboration: Collaborate with cross-functional teams, including Quality Assurance, Research and Development, and Production, to drive process improvements and resolve issues.
- Troubleshooting: Investigate and troubleshoot process deviations and quality issues, implementing corrective and preventive actions (CAPA) as necessary.
- Technology Transfer: Support technology transfer activities between development and manufacturing sites.
- Training: Provide training to production and quality personnel on validation procedures and best practices.
- Bachelor's degree in chemical engineering, pharmaceutical sciences, or a related field.
- Proven experience in pharmaceutical process validation, including equipment, process, and cleaning validation.
- Strong knowledge of cGMP regulations and FDA guidelines.
- Excellent problem-solving and analytical skills.
- Proficiency in validation software and statistical analysis tools.
- Effective communication and teamwork skills.
- Detail-oriented with a strong commitment to quality and compliance.
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