Job Description

Operating within the Global Data Systems Quality organization supporting Business and Information Technology teams, the Computer System Validation (CSV) Lead will be leading all phases of the CSV Lifecycle from validation planning, requirement definition, Part 11 assessments, risk assessments, Test plan reviews and reporting for Agilent's Pathology business. The CSV Lead may perform this independently or with a supporting CSV Engineer(s), depending upon the scope of the validation.

This role will guide the CSV Engineers across the company under the One QMS CSV program on CSV best practices based on their established expertise. Support the CSV Engineers directly during the validation projects or via the Community of Practice sessions. This role will work closely with Agilent’s business teams, quality and IT to plan, implement and maintain the validation for GxP Systems. This includes the development of new systems, change management for existing systems and data migration activities.

Essential Responsibilities:

Develop validation plans, data migration plans, test plans and associated reports to demonstrate that Agilent computerized systems meet the intended use and comply with regulatory requirements.

Review project team deliverables to ensure validation efforts are executed to plan, properly authored and in alignment with internal CSV process requirements and FDA/EU and ISO regulations.

Work directly under the Director of Data Systems Quality and provide guidance to the CSV Engineers within DSQ and across Agilent under the One QMS CSV program.

Support the Director of Data Systems Quality in leading the One QMS CSV Community of Practice and presenting on key topics.

Review and refine use cases and user requirements as needed from the business stakeholders to establish the intended use of Agilent’s computerized systems.

Ensure validated systems remain in compliance with industry standards as changes to applications are made, including the revalidation of applications as needed based upon impact assessments.

Act as a CSV SME for FDA inspections, notified body audits and other internal / external audits as needed.

Develop Agilent’s validation procedures. Review and approve changes to existing IT QMS processes and technical procedures.

Perform other duties as identified by the Director of Data Systems Quality.

Key Duties and Responsibilities:

Maintain the validated state of GxP Computer systems by leading the project teams and CSV engineers on the CSV process for initial GxP Computer System release and during change management.

Support the continuous development of the CSV process by creating and / or updating assigned CSV process documentation and training.

Serve as an SME for CSV Engineers across Agilent under the One QMS CSV program based on established and learned expertise.

Qualifications

Bachelor's degree in Computer Science, IT, Systems Engineering, or other engineering specialization with experience in Information Technology, computer system compliance and/or system/software validation.

8+ years of relevant experience in diagnostic, medical devices and/or pharmaceutical industry software applications.

Experience as a Subject Matter Expert in multifunctional teams, providing guidance on CSV best practices.

Hands on validation experience within regulated environment required, including authoring Validation Plans, Test Plans, Assessments and Reports.

Profound knowledge of medical device/IVD software regulations such as FDA CFR 21 Part 820 and Part 11, ISO13485, 14969, ISO 14971 and GAMP 5.

GxP experience in Pharma or Med Devices with Quality Management System (QMS) records (e.g. Deviations, CAPAs, Change Management).

Prefer knowledge on data integrity, software development lifecycles, Agile software development in a regulated environment and/or similar compliant software practices.

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least September 19, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $127,544.00 - $199,288.00/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 job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Travel Required: Occasional

Shift: Day

Duration: No End Date

Job Function: Quality/Regulatory