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Leading Validation Expert for Sterile Drug Products
2 weeks ago
We are seeking an experienced and skilled professional to join our team as a Senior Validation Engineer. In this role, you will contribute to the Sterile Drug Product Facility project, serving as an integral member of the Commissioning, Qualification, and Validation (CQV) team.
Your key responsibilities will include creating and implementing commissioning and qualification plans for equipment and systems, conducting start-up activities, and developing validation protocols to verify equipment and system installation, operation, and performance.
- Create and implement commissioning and qualification plans for equipment and systems
- Conduct equipment and system start-up activities, including initial power-up, configuration, functional testing, and troubleshooting
- Develop and execute IQ, OQ, and PQ protocols to verify equipment and systems installation, operation, and performance
- Develop and execute validation protocols to support facility, utility, equipment, and computerized system qualification
- Ensure all validation activities comply with regulatory requirements and industry best practices
- Bachelor's degree in a scientific, technical, or engineering discipline
- Prior GMP experience is essential
- Previous CQV experience is a significant advantage
- Biopharmaceutical process and validation knowledge preferred
- Experience working in a drug product filling facility is desirable
To be successful in this role, you should have a strong understanding of GMP regulations and industry best practices. You should also be able to work effectively in a team environment and communicate complex ideas clearly.
This is an exciting opportunity to join a dynamic team and contribute to the success of our organization. If you are a motivated and detail-oriented individual with a passion for validation, we encourage you to apply.
