Validation Project Manager

We are seeking an experienced Validation Project Manager to join our team in the biomedical industry. The Validation Project Manager will be responsible for managing the validation process for equipment, systems, and processes used in the manufacture of our medical devices. This includes managing validation projects from start to finish, developing and executing validation protocols, and ensuring compliance with industry standards and regulations.

Key Responsibilities:

• Develop and manage project timelines and budgets for validation projects
• Coordinate with cross-functional teams to ensure successful project execution
• Develop and execute validation protocols and reports for equipment, systems, and processes
• Ensure compliance with industry standards and regulations, including FDA regulations and ISO standards
• Lead risk assessments and develop risk mitigation strategies for validation projects
• Conduct investigations into deviations and ensure appropriate corrective actions are implemented
• Manage change control for validated systems and processes

Qualifications:

• Bachelor’s or Master’s degree in a relevant scientific field (e.g., Biomedical Engineering, Chemical Engineering, or related field)
• No Degree required with the right experience
• Experience in validation project management within the biomedical industry
• Strong understanding of FDA regulations and ISO standards related to validation and manufacturing of medical devices
• Experience with equipment qualification and process validation
• Excellent project management skills, including the ability to manage multiple projects simultaneously

If you meet these qualifications and are interested in this opportunity, please submit your resume and any info on your career situation and interests. EEO – We are an equal opportunity employer and welcome all qualified candidates to apply.