Qualifications

• Bachelor's degree in Mechanical Engineering or a related Life Science/Engineering field.
• 3 years' experience in Validation Engineering in FDA regulated environments.
• Proficient in developing IQ/OQ/PQ validation protocols for medical devices.
• Strong understanding of regulatory guidelines specific to medical device manufacturing.
• Experience collaborating with cross-functional teams including engineering and R&D.

Responsibilities

• Develop IQ/OQ/PQ protocols for equipment in a regulated environment.
• Coordinate and conduct equipment qualifications to ensure compliance.
• Document procedures to validate products and processes effectively.
• Work with engineering and operations teams to streamline validation processes.
• Ensure automated process equipment meets regulatory specifications and safety requirements.

Benefits

• Opportunities for professional development and training.
• Collaborative work environment with cross-functional teams.
• Health and wellness benefits.
• Contributions to innovative medical product solutions.
• Potential for career advancement within the company.