Process/Validation Engineer
4 weeks ago
- 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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Process Engineer
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Quality Engineer II
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Durham, United States BioAgilytix Full timeAt BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . ....
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Durham, United States Beam Therapeutics Inc. Full timePosition Overview: The Vice President, Process Performance Qualification and Validation will be responsible for the overall establishment of Beam's Global Validation Program for Process Performance Qualification (PPQ) / Continuous Process Verification (CPV), creation of program specific validation strategies and management of the overall validation program....
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Quality Engineer II
4 days ago
Durham, United States BioAgilytix Full timeAt BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . ....
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Senior MSAT/Process Engineer
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Senior/ Lead Process Engineer
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