Agilent Technologies, Inc.
Manufacturing/Validation Engineer
Agilent Technologies, Inc., Carpinteria, California, us, 93014
Manufacturing/Validation Engineer page is loaded## Manufacturing/Validation Engineerlocations:
US-CA-Carpinteriatime type:
Full timeposted on:
Posted Todayjob requisition id:
4033719## **Job Description**## Lead the qualification of production equipment and the validation of manufacturing processes in a regulated medical-device environment. Create URS and FMEA documentation, execute risk-based IQ/OQ/PQ/SQ, support CAPA/NCRs, manage cross-functional projects, drive CI/Six Sigma improvements, write SOPs, and train production staff—ensuring compliance with 21 CFR Part 820, 21 CFR Part 11, and ISO 13485.## **Role Description*** **Equipment Qualification & Process Validation:** Develop URS, conduct risk assessments, plan/execute **IQ/OQ/PQ**/**SQ,** manage deviations, and produce audit-ready reports.* **CAPA/NCR Support:** Lead/participate in root-cause investigations, define corrective/preventive actions, verify effectiveness, and maintain clear documentation* **Project Management:** Build schedules and budgets, coordinate vendors, track risks/issues, and report status to stakeholders through stage-gate milestones.* **CI / Six Sigma:** Apply DMAIC, PFMEA, SPC/CPK, MSA/Gage R&R, and DOE to reduce waste, improve yield/throughput, and sustain process capability.* **SOP & Document Control:** Author and revise SOPs, work instructions, forms, and validation documentation under change control; maintain inspection-ready files.* **Training & Enablement:** Develop training materials; coach technicians and operators on new equipment, validated processes, and documentation standards.* **Compliance & Readiness:** Support internal/external audits; ensure Part 11 data integrity (ALCOA+) for computerized/automated systems.## ## ## **Qualifications*** B.S. in Mechanical, Electrical, Chemical, Biomedical, Industrial or related engineering field.* **4+ years** in medical device (or similarly regulated) manufacturing.* Hands-on ownership of **URS, FMEA**, and **IQ/OQ/PQ/SQ** deliverables for equipment and processes.* Experience supporting **CAPA/NCR** lifecycle* Working knowledge of **21 CFR 820**, **21 CFR Part 11**, **ISO 13485*** Strong technical writing and cross-functional communication; solid project coordination skills.**Nice to Have*** Exposure to **automation/MES/SCADA/PLC**, data acquisition, or vision/inspection systems.* Proficiency with **Lean/Six Sigma** methods (5S, VSM, SPC, DOE, MSA); **Six Sigma Green Belt** preferred.* Tools: Agile PLM, MS Project/Smartsheet; basic SQL/Power BI a plus.* Certifications: **PMP**,**Additional Details**This job has a full time weekly schedule. Applications for this job will be accepted until at least October 1, 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $104,774.00 - $163,710.00/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/locationsAgilent 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:**Manufacturing #J-18808-Ljbffr
US-CA-Carpinteriatime type:
Full timeposted on:
Posted Todayjob requisition id:
4033719## **Job Description**## Lead the qualification of production equipment and the validation of manufacturing processes in a regulated medical-device environment. Create URS and FMEA documentation, execute risk-based IQ/OQ/PQ/SQ, support CAPA/NCRs, manage cross-functional projects, drive CI/Six Sigma improvements, write SOPs, and train production staff—ensuring compliance with 21 CFR Part 820, 21 CFR Part 11, and ISO 13485.## **Role Description*** **Equipment Qualification & Process Validation:** Develop URS, conduct risk assessments, plan/execute **IQ/OQ/PQ**/**SQ,** manage deviations, and produce audit-ready reports.* **CAPA/NCR Support:** Lead/participate in root-cause investigations, define corrective/preventive actions, verify effectiveness, and maintain clear documentation* **Project Management:** Build schedules and budgets, coordinate vendors, track risks/issues, and report status to stakeholders through stage-gate milestones.* **CI / Six Sigma:** Apply DMAIC, PFMEA, SPC/CPK, MSA/Gage R&R, and DOE to reduce waste, improve yield/throughput, and sustain process capability.* **SOP & Document Control:** Author and revise SOPs, work instructions, forms, and validation documentation under change control; maintain inspection-ready files.* **Training & Enablement:** Develop training materials; coach technicians and operators on new equipment, validated processes, and documentation standards.* **Compliance & Readiness:** Support internal/external audits; ensure Part 11 data integrity (ALCOA+) for computerized/automated systems.## ## ## **Qualifications*** B.S. in Mechanical, Electrical, Chemical, Biomedical, Industrial or related engineering field.* **4+ years** in medical device (or similarly regulated) manufacturing.* Hands-on ownership of **URS, FMEA**, and **IQ/OQ/PQ/SQ** deliverables for equipment and processes.* Experience supporting **CAPA/NCR** lifecycle* Working knowledge of **21 CFR 820**, **21 CFR Part 11**, **ISO 13485*** Strong technical writing and cross-functional communication; solid project coordination skills.**Nice to Have*** Exposure to **automation/MES/SCADA/PLC**, data acquisition, or vision/inspection systems.* Proficiency with **Lean/Six Sigma** methods (5S, VSM, SPC, DOE, MSA); **Six Sigma Green Belt** preferred.* Tools: Agile PLM, MS Project/Smartsheet; basic SQL/Power BI a plus.* Certifications: **PMP**,**Additional Details**This job has a full time weekly schedule. Applications for this job will be accepted until at least October 1, 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $104,774.00 - $163,710.00/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/locationsAgilent 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:**Manufacturing #J-18808-Ljbffr