Job Description
- Validation Protocols: Develop, execute, and document validation protocols for equipment, processes, and systems in compliance with GMP regulations and industry standards.
- Documentation: Prepare and review validation documentation, including protocols, reports, and standard operating procedures (SOPs), ensuring accuracy and completeness.
- Compliance: Ensure that all validation activities adhere to GMP guidelines, regulatory requirements, and internal quality standards.
- Risk Management: Identify and assess potential risks in validation processes, and implement strategies to mitigate those risks.
- Continuous Improvement: Collaborate with cross-functional teams to optimize validation processes and procedures, contributing to continuous improvement initiatives.
- Training and Support: Provide training and support to facility staff on validation procedures and compliance requirements.
- Troubleshooting: Investigate and resolve validation-related issues and deviations, providing technical expertise and guidance as needed.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Validation engineering within a GMP environment, with a strong understanding of validation principles and regulatory requirements.
- Proficiency in validation methodologies, risk management, and quality systems. Familiarity with FDA regulations, EU guidelines, and other relevant standards.
- Excellent analytical, problem-solving, and organizational skills. Strong attention to detail and the ability to work independently and as part of a team.
- Effective written and verbal communication skills, with the ability to present complex information clearly to diverse audiences.
