We are searching for a Validation Engineer for our client in NE Atlanta. The Validation Engineer is responsible for ensuring compliance with regulatory requirements for equipment, processes, and sterilization validation. This role involves developing, executing, and documenting validation protocols, including EtO (Ethylene Oxide) sterilization, in alignment with ISO, FDA, and GMP standards.
Our client is a pioneering medical technology company dedicated to advancing patient care through innovative solutions. With a rich history spanning over five decades, they have established themselves as a global leader in the design and manufacture of high-quality medical devices. New to the US, this is the perfect opportunity for someone who wants to work in a less-corporate culture with more autonomy and opportunity for growth.
Requirements:
Bachelor’s degree preferred.
2–5 years of experience in validation within a medical device, pharmaceutical, or other regulated industry.
Strong understanding of ISO 13485, ISO 11135, FDA 21 CFR 820, and GMP requirements.
Experience with EtO sterilization validation.
Proficiency in validation tools, statistical analysis, and risk management techniques.
Experience with electronic QMS systems (preferred).
Certification in validation (e.g., ASQ CQE) (preferred).
Responsibilities:
Develop, execute, and maintain IQ/OQ/PQ validation protocols for manufacturing equipment, processes, and facilities.
Lead validation efforts for EtO sterilization processes, ensuring compliance with ISO 11135 and other relevant standards.
Conduct risk assessments and statistical analysis to support validation activities.
Develop and implement process validation strategies aligned with industry best practices and regulatory expectations.
Ensure validation activities comply with FDA 21 CFR Part 820, ISO 13485, ISO 11135, and other applicable regulations.
Maintain validation documentation, ensuring traceability and compliance with QMS requirements.
Support qualification of new equipment and facility modifications through documented validation activities.
Identify and implement improvements to validation processes to enhance efficiency and compliance.
