Process Validation Engineer
Listed on 2026-06-26
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Regulatory Compliance Specialist
Job Title:
Process Validation Engineer
Location:
San Jose, CA
Duration: 5+ Months
Client:
Medical Device Company
Employment Type:
Contract on W2 (US Citizens or GC Holders Only)
No H1B’s.
Work hours:
40 hours/week. Will work virtually from home and on site at the San Jose, California facility.
Operations
Responsible for performing process, equipment, and software validation activities including laboratory studies and validations, gathering historical data for product manufacture, analyzing data using statistical principles, writing process validation protocols and reports, technical review of data and reports, and final approval of protocols, reports, and deviations. May interact in cross‑functional teams including reagent manufacturing engineers, chemists, research and development, and quality assurance validation engineers.
Must be able to work independently and simultaneously on multiple projects. Knowledge of general reagent manufacturing processes, antibody purification and conjugation, and flow cytometry is preferred.
- Process, test method, equipment, and software validations used in IVD product manufacture (IQ, OQ, PQ)
- Hands‑on laboratory studies
- Review/approve or author validation protocols, reports, and deviations
- Provide and apply direction to projects using quality and statistical principles
- Root Cause Analysis, FMEA, DOE
- Measurement systems analysis, sampling and control plans
- Post‑market surveillance trend review, process capability analysis
- Follow company procedures
- Other duties as assigned
- Bachelor’s degree in biology, chemistry, biotechnology or similar
- Hands‑on lab experience
- Process validation experience
- Experience in a manufacturing or R&D function in a medical device or FDA‑regulated environment
- Previous work with IVD reagent products under GMP conditions
- Process, test method, and software validation experience (IQ, OQ, PQ)
- Knowledge of general reagent manufacturing processes, antibody purification, conjugation, flow cytometry
- Six Sigma certification
- Knowledge of applicable regulatory requirements including ISO
13485, ISO
14971, ISO
9001, 21 CFR 820 - Training in statistics; experience with Minitab or other statistical software, MS Excel, and MS Word
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