paycor
Validation Engineer
BWI Chassis Dynamics (NA) Inc.
Brighton, USA
Full-time
Mid Level
Onsite
Discovered 1 weeks ago
Free
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- Establish validation and qualification criteria for products and systems based on specifications and regulatory requirements.
- Develop, review, and execute validation master plans and protocols (for example DVPRs, test plans, and traceability).
- Create and run tests to evaluate system performance, capability, and repeatability against approved protocols.
- Oversee calibration, verification, and maintenance of instruments and equipment used in validation activities.
- Analyze test data using appropriate statistical methods and summarize results in validation reports with clear conclusions and recommendations.
- Identify deviations, nonconformances, and risks; lead or support root cause investigations and implementation of corrective and preventive actions (CAPA).
- Maintain validation documentation including protocols, reports, risk assessments, traceability matrices, and activity logs in accordance with quality system requirements.
- Ensure systems remain in a validated state through periodic review, revalidation, and change control support.
- Collaborate with engineering, quality, manufacturing, IT, and suppliers during design, commissioning, and qualification of new or modified equipment and processes.
- Support internal and external audits or inspections by providing validation documentation and subject‑matter expertise.
- Train or mentor technicians and junior team members on validation procedures, test methods, and documentation practices as needed.
- Ensure validation activities comply with applicable regulations and standards (for example ISO 9001 and IATF 16949, and relevant product standards).
- Bachelor’s degree in Mechanical, Electrical, Chemical, Biomedical, or related Engineering or a closely related scientific field.
- Experience in validation, test, quality, or process engineering in a manufacturing or laboratory environment (internships or co‑ops for entry level).
- Strong understanding of manufacturing processes, quality systems, and applicable safety or regulatory requirements.
- Ability to develop and execute validation protocols, analyze technical data, and write clear technical reports.
- Knowledge of statistical analysis tools or software (for example, MATLAB, Minitab, EMC, or similar).
- Excellent attention to detail, organizational skills, and ability to manage multiple validation activities and deadlines.
- Effective communication and teamwork skills to work across engineering, quality, and operations teams.
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