About the role

Aplyr's Quick Take

This role is about ensuring that manufacturing equipment and systems for cancer diagnostic kits meet regulatory standards. You'll be executing validation protocols, supporting production teams, and collaborating with various departments to maintain compliance and improve processes. It's an individual contributor role focused on technical validation tasks.

Good fit

Ideal candidates have at least 2 years of experience in validation or manufacturing engineering, preferably in a regulated environment like medical devices or diagnostics. A detail-oriented approach and familiarity with quality systems and validation principles are essential.

Worth noting

The position emphasizes collaboration across multiple teams, which could be a plus for those who enjoy teamwork. The salary range is competitive for the industry, but the role may involve high-stakes responsibilities due to the nature of the products being manufactured.

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 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:

10% of the Time

Shift:

Day

Duration:

No End Date

Job Function:

Manufacturing

Aplyr's read

Agilent Technologies excels in life sciences and diagnostics, attracting professionals skilled in engineering, software, and scientific research.
Synthesized from recent postings & public sources

What's promising

•Agilent is a leader in life sciences and diagnostics, offering cutting-edge technology.
•The company invests heavily in R&D, driving innovation in laboratory solutions.
•Agilent's global presence provides diverse career opportunities in various regions.

What to watch

•Highly competitive industry may pressure Agilent to continuously innovate.
•Fluctuations in global markets can impact financial stability and growth.
•Complex product lines require specialized knowledge, limiting entry-level opportunities.

Why Agilent Technologies

•Agilent integrates advanced technology with scientific expertise for comprehensive lab solutions.
•The company offers a unique portfolio in applied chemical markets.
•Agilent's strong focus on diagnostics differentiates it from competitors in life sciences.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Agilent Technologies

Agilent Technologies

agilent.com

View company

Agilent Technologies is a global leader in life sciences, diagnostics, and applied chemical markets, providing instruments, software, services, and consumables for laboratories.