Seeking a Validation Engineer for a consulting position at a medical devices client in Irvine, CA 92618.
• 2+ years’ experience with manufacturing engineering or validation experience.
• Understanding of manufacturing processes and related process equipment.
• Working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
• Proficient in writing and reviewing protocols and technical reports.
• Experience working in the medical device industry preferred.
• Experience working with a sterile packaging environment a plus.
• Bachelor's degree in Engineering or equivalent years of relevant engineering-level experience
Support validation of new and existing equipment and processes for production line usage. The Validation Engineer will be responsible for creating and executing validation procedures to support company goals. These validation activities will include development and revision of validation protocols and procedures, develop test plan traceability matrix, qualification and re-qualification of process equipment (IQ/OQ/PQ), and prepare reports.
• Ensure that assigned validation activities are performed timely and in line with the current company requirements and cGMP, handling any deviations associated with these activities.
• Author validation protocols and technical reports (e.g., Pre Validation Studies, Performance Qualifications, Requalification)
• Perform process qualification for new equipment and new technologies.
• Author validation protocols and engineering studies.
• Contribute to provide experimental data obtained during the validation activities.
• Perform or oversee risk assessments for Validation.
• Participate in the improvement and remediation of products.
• Maintain assigned documentation and work area in inspection readiness level and provide necessary support in any internal or external audit.
• Meet established validation and revalidation milestones according to approved validation plans that do not adversely impact production schedule nor audit readiness.
• Technical reports executed on time and with the right expectations.
• Technical/scientific responsibility as member of the site Subject Matter Experts (SME) team.
• Training curriculum up-to-date. All contractors (if assigned) trained according to the training curriculum.