Validation Engineer

Validation EngineerThe Validation Engineer supports the development, qualification, validation, and ongoing control of manufacturing processes, equipment, computerized systems, and related quality systems used in the manufacture of medical devices. This role plans and executes validation and qualification activities, prepares clear and compliant validation documentation, analyzes data using appropriate statistical methods, and collaborates closely with Quality, Production, Engineering, R&D, Regulatory, and other departments. The position also contributes to material qualifications, product changes, product development support, and other quality or engineering projects as business needs evolve.ResponsibilitiesSupport sustaining activities for existing products to ensure stable, compliant, and efficient manufacturing processes.Support research and development efforts for modified and new products and processes, helping to bring them from concept into routine production.Understand and serve internal and external customer needs and expectations when planning and executing validation activities.Adhere to internal policies, procedures, and quality-system requirements in all validation and documentation work.Collaborate with cross-functional teams to support timely commercialization of changed and new products.Plan, coordinate, execute, and document equipment and process validation activities in accordance with regulatory and quality-system expectations.Develop, execute, and maintain qualification and validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), as appropriate.Develop validation strategies and determine suitable testing approaches based on process requirements, risk, intended use, and applicable regulations and standards.Prepare validation plans, protocols, reports, risk assessments, test records, deviations, and other validation-related documentation with a high level of accuracy and traceability.Evaluate validation data and apply appropriate statistical methods to demonstrate process capability, consistency, and acceptance criteria.Support validation and revalidation of manufacturing equipment, packaging equipment, inspection systems, test equipment, utilities, cleanroom-related systems, and manufacturing processes.Assess equipment, process, software, and system changes to determine validation or revalidation requirements and document the rationale.Support investigation and resolution of validation deviations and unexpected results, including root-cause analysis and corrective actions.Provide ongoing validation support for existing manufacturing processes and equipment to maintain a validated state.Support validation of computerized systems used within the Quality Management System and manufacturing environment.Participate in validation of electronic QMS applications, equipment software, automated inspection systems, data collection systems, and other computerized systems used in regulated activities.Develop and execute software and computerized-system validation documentation using a risk-based approach appropriate to each systems intended use.Participate in assessment and validation of software updates, patches, configuration changes, and new functionality.Work with system owners, vendors, IT, Quality, and other stakeholders to define system requirements, testing strategies, documentation, and activities needed to maintain a validated state.Support compliance with applicable electronic-record, electronic-signature, data-integrity, and computerized-system regulations and guidance.Support the development and improvement of manufacturing processes for both existing and new products.Assist with process troubleshooting, investigations, and continuous-improvement initiatives to enhance quality, yield, and efficiency.Collaborate with Production and Engineering to transition new or modified equipment and processes into routine manufacturing.Evaluate process changes for potential impact on validated state, product quality, and associated documentation, and recommend appropriate actions.Support second-source materials, alternate equipment, manufacturing changes, and other sustaining engineering projects as assigned.Support material qualification activities, including developing test plans, coordinating testing, analyzing results, and preparing qualification documentation.Provide validation and manufacturing-process input to product-development and product-change projects.Participate in cross-functional project teams involving Quality, R&D, Regulatory, Production, Engineering, and other departments.Support product development activities when needed, while recognizing that product design and material development are not the primary responsibilities of this role.Draft, review, and revise procedures, work instructions, specifications, forms, validation documents, and other controlled records.Ensure validation documentation is accurate, complete, traceable, and suitable for internal and external audit review.Support investigations, nonconformances, CAPAs, change controls, risk assessments, and other Quality System activities that require validation or engineering expertise.Maintain organized project records and ensure validation documentation is appropriately controlled within the Quality Management System.Provide technical support during internal, regulatory, and certification audits related to validation and manufacturing processes.Plan and organize assigned validation and qualification projects, defining scope, deliverables, and timelines.Coordinate validation and qualification activities with Production, Engineering, Quality, R&D, Regulatory, vendors, laboratories, contractors, and other stakeholders.Identify project requirements, dependencies, risks, resource needs, and scheduling constraints and communicate them proactively.Communicate project status, technical issues, and resource needs clearly to management and project stakeholders.Manage multiple concurrent projects and changing priorities while maintaining strong documentation practices and high quality standards.Essential SkillsBachelors degree in Engineering, Science, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Manufacturing Engineering, or a related technical discipline.Approximately 4+ years of engineering, validation, quality, manufacturing, or related experience in the medical device, pharmaceutical, biotechnology, or other regulated industry preferred.Hands-on experience performing or supporting equipment and/or process validation, including planning, execution, and documentation, strongly preferred.Experience developing and executing IQ/OQ/PQ protocols and reports in a regulated environment preferred.Knowledge of validation principles for equipment and processes, including process validation and equipment validation.Ability to prepare and manage validation protocols, reports, risk assessments, and other technical documentation.Experience with statistical analysis and interpretation of validation data to demonstrate process capability and acceptance.Proficiency with Microsoft Excel and other data-analysis tools used to organize, analyze, and present validation results.Familiarity with Electronic Quality Management Systems (eQMS) and working within a controlled-document environment.Understanding of computerized system validation (CSV) and/or computer software assurance (CSA) concepts and their application in regulated environments.Ability to support validation of manufacturing or laboratory equipment software, including automated inspection or vision systems.Understanding of requirements for electronic records and electronic signatures in regulated industries.Strong written and verbal communication skills to produce clear validation documentation and collaborate across departments.Ability to manage multiple projects, prioritize tasks, and meet deadlines while maintaining high documentation and quality standards.Additional Skills & QualificationsAdvanced degree in a relevant engineering or scientific discipline is desirable.Experience in medical device manufacturing is preferred; experience in pharmaceutical, biotechnology, or automotive industries is also considered valuable.Experience with Test Method Validation (TMV) and contribution to a Master Validation Plan is beneficial, though not required.Experience with computerized software validation is a plus but not mandatory.Familiarity with automated inspection or vision systems and related validation activities is advantageous.Basic database, programming, data manipulation, or automation skills are beneficial but not required.CAD experience is beneficial but not required.Comfort working in a small to mid-sized organization with close collaboration across Quality, Production, Engineering, and other functions.Work EnvironmentThis role operates within a regulated manufacturing and quality environment focused on medical devices and other highly controlled products. The Validation Engineer works closely with a Quality team of approximately a dozen professionals and interacts regularly with Production, Engineering, R&D, Regulatory, IT, vendors, laboratories, and contractors. Work involves both office-based taskssuch as developing validation strategies, analyzing data in Microsoft Excel, and maintaining documentation in an Electronic Quality Management Systemand time on the manufacturing floor or in laboratory areas to support equipment, process, and computerized-system validation. The environment emphasizes compliance with quality-system requirements, electronic records and signatures, and data integrity expectations. Employees collaborate in cross-functional project teams, manage multiple concurrent projects, and adapt to changing priorities while maintaining high standards for documentation, safety, and product quality. Attire is appropriate for a professional, regulated manufacturing setting, with additional gowning or protective equipment as required in production or