Job Summary:
Lead or support the execution of protocols for manufacturing systems to ensure compliance with regulatory requirements.
Key Responsibilities:
* Develop and manage documentation for equipment qualification and validation
* Collaborate with cross-functional teams to align on qualification strategies and ensure regulatory compliance
* Ensure adherence to GMP, EU/FDA regulations, and internal quality standards
* Participate in deviation investigations, cycle development, and performance qualification reporting
* Support vendor testing and leverage results for qualification
* Maintain and update the Equipment Validation Master Plan
Requirements:
* Bachelor's degree in a related field such as engineering, science, or a relevant technical discipline
* Proven experience in a similar role with a focus on regulatory compliance and equipment qualification
* Strong understanding of GMP, EU/FDA regulations, and internal quality standards
* Excellent communication and collaboration skills
Benefits:
* A competitive compensation package
* Ongoing training and professional development opportunities
* A collaborative and dynamic work environment