Validation Engineer

Validation Engineer Agilent Technologies, Inc. - 4.0 Carpinteria, CA Job Details Full-time $88,254 - $137,896 a year 3 hours ago Qualifications Regulatory compliance Manufacturing facility Production validation processes Biomedical regulatory compliance Test validation method

ISO 13485

Full Job Description Job Description Reports into the Manufacturing engineering function. The Carpinteria site manufactures cancer diagnostic kits that provide patients with trusted answers. The Validation Engineer supports validation and sustaining engineering activities for manufacturing equipment and systems in a regulated IVD environment, with emphasis on automation and controlled temperature systems. Key Responsibilities Execute validation activities across the equipment and software lifecycle, including IQ/OQ/PQ, to support new equipment introduction, changes, and maintenance of the validated state Author and execute validation protocols and reports in compliance with quality system requirements Provide direct support to production teams to ensure equipment readiness and sustained compliance, including execution of IQ/OQ activities Support qualification of automation systems (PLC-controlled equipment, vision systems, labeling platforms), software and controlled temperature/refrigeration units Support validation of facility and infrastructure changes, including utilities and environmental conditions Apply statistical sampling best practices and statistical methods to evaluate reliability and product quality Develop and execute Gage R&R studies for test methods and inspection systems Contribute to process risk analysis (e.g., FMEA) to identify and mitigate risks Support supplier evaluation and qualification of materials and components for lifecycle sustaining This role will work within the Global Operations Manufacturing team to support the site ma activities Lead quality improvement efforts to reduce department nonconformances, and drive action through continuous improvement or CAPA. Collaborate cross-functionally with Manufacturing Operations, Process Engineering, MSAT, Quality Assurance, and Regulatory Affairs to support manufacturing design updates, labeling changes, and process improvements Qualifications Bachelor's degree in engineering or related technical discipline, or equivalent combination of education and relevant experience 2+ years of experience in manufacturing engineering, validation, or operations support within a regulated environment. Experience in medical devices, diagnostics, pharmaceutical, or IVD manufacturing environments with Working knowledge of ISO 13485, FDA, and MDSAP requirements Working knowledge of equipment and software qualification and validation principles (IQ/OQ/PQ) Strong attention to detail and documentation discipline Preferred Qualifications Hands-on experience with automation technologies in downstream fill and assembly operations (PLC-controlled systems, vision inspection systems, labeling equipment) Experience working with controlled temperature and refrigeration systems (e.g., refrigerators, freezers, incubators, cold rooms) Working knowledge using statistical tools (Minitab) for statistics-based approach to validation. Additional Details This job has a full time weekly schedule. Applications for this job will be accepted until at least May 29, 2026 or until the job is no longer posted. The full-time equivalent pay range for this position is $88,254.00 - $137,896.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Travel Required:

10% of the

Time Shift:

Day Duration:

No End Date Job Function:

Manufacturing