| Process Validation Engineers at GRAND MARAIS, MI [onsite role] at Grand, New York, USA |
| Email: [email protected] |
| From: Devyani Kumari, Absolute IT [email protected] Reply to: [email protected] Process Validation Engineers 3-6 moth contract GRAND MARAIS , MI [onsite role] Rate - $50/hr on C2C 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. Requirements: 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. Keywords: information technology Michigan |
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| Mon Feb 26 22:26:00 UTC 2024 |