Validation Engineer (Carlsbad)

Title: Validation EngineerLocation: Carlsbad, CA**Onsite Interview**Job SummaryWe are seeking a Validation Engineer II to support validation activities for manufacturing systems, production processes, and quality systems within a regulated medical device environment. This role will be responsible for developing, executing, and maintaining validation programs and documentation in compliance with internal quality standards and regulatory requirements. The ideal candidate will have experience in process validation, equipment validation, change control assessment, and protocol execution within FDA-regulated environments.Key ResponsibilitiesDevelop, execute, and maintain validation documentation for manufacturing systems, equipment, and processes in compliance with internal and external regulatory requirements.Author and manage validation protocols, reports, and Validation Master Plans (VMPs).Lead execution of validation protocols and ensure timely completion of validation activities.Evaluate and analyze validation results and prepare final validation reports.Support validation activities related to new product introductions and existing manufacturing processes.Review and assess Change Management documentation including process, system, and document changes.Track validation project progress and provide status updates through departmental tracking systems.Support internal and external audits related to validation activities and documentation.Collaborate cross-functionally with Manufacturing, Quality, Engineering, and Regulatory teams.Provide technical guidance and mentorship to junior team members when needed.Ensure compliance with FDA, GMP, and Quality System requirements.Required QualificationsBachelor's Degree in Engineering, Life Sciences, or related technical field.Minimum 2–3 years of validation engineering experience in a regulated industry.Experience with process validation, equipment qualification, and validation lifecycle activities.Strong understanding of GMP, FDA, and quality system regulations.Experience writing and executing IQ/OQ/PQ protocols and validation reports.Familiarity with Change Control and CAPA systems.Strong technical writing, analytical, and communication skills.Ability to manage multiple validation projects and priorities simultaneously.Preferred QualificationsMaster's Degree in a related field.Experience in medical device, pharmaceutical, or biotech manufacturing environments.Experience supporting audits and regulatory inspections.Knowledge of validation project tracking tools and risk-based validation approaches.