Validation Engineer

Job Summary We are seeking a highly motivated Validation Engineer to join our dynamic manufacturing and quality assurance team. In this role, you will be responsible for developing, executing, and overseeing validation protocols to ensure that manufacturing processes, equipment, and systems comply with industry standards and regulatory requirements. The ideal candidate will play a pivotal role in maintaining the integrity of quality systems, supporting compliance with ISO 13485, FDA regulations, HACCP, CGMP, ISO 9001, and other relevant standards. This position offers an opportunity to contribute to the continuous improvement of product quality and operational excellence through meticulous validation practices. Responsibilities Develop comprehensive validation protocols for manufacturing processes, equipment qualification, and system validation in accordance with regulatory standards. Execute validation activities including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Collaborate with cross-functional teams to ensure validation activities align with project timelines and quality objectives. Conduct thorough documentation of validation results, deviations, and corrective actions to ensure traceability and compliance. Perform risk assessments related to manufacturing processes and implement mitigation strategies as needed. Support ongoing calibration, maintenance, and revalidation efforts to sustain validated states. Participate in quality audits and inspections related to validation activities to verify adherence to applicable standards. Maintain up-to-date knowledge of industry regulations such as ISO 13485, FDA guidelines, HACCP, CGMP, and ISO 9001. Contribute to continuous improvement initiatives by analyzing validation data and recommending process enhancements. Assist in training team members on validation procedures and compliance requirements. Experience Bachelor's degree in Engineering, Life Sciences, or a related field; advanced certifications in Validation or Quality Assurance are preferred. Proven experience in validation within regulated manufacturing environments such as medical devices, pharmaceuticals, or food industries. Strong understanding of regulatory frameworks including ISO 13485, FDA regulations (21 CFR Part 11), HACCP principles, CGMP practices, and ISO 9001 standards. Demonstrated expertise in developing and executing validation protocols for equipment and processes. Knowledge of quality systems management including QA/QC procedures and quality audits. Excellent analysis skills with the ability to interpret data accurately and identify root causes of issues. Project management skills with the ability to prioritize tasks effectively while managing multiple projects simultaneously. This position offers an engaging environment where your expertise will directly impact product safety and quality. We welcome candidates committed to excellence in validation practices who are eager to contribute to our mission of delivering high-quality products through rigorous quality management systems. Pay: $72,000.00 - $90,000.00 per year Work Location: In person