Process Validation Engineer

Hello There, We at Millenniumsoft looking for Process Validation Engineer who is responsible for performing process, equipment, and software validation activities including, but not limited to, gathering historical data for product manufacture, analyzing data using statistical principles, writing validation protocols and reports, GDP review of data and reports, and final approval of validation protocols, reports, and deviations.

Title: Process Validation Engineer

Location: San Jose, CA

Contract Term: 12+ Months

Weekly

Hours:

40.00 hours

Shift: 1st Shift

Client: Medical Device Company

Job Category: Engineering

Level Of

Experience:

Seniority Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Responsible for performing process, equipment, and software validation activities including, but not limited to, gathering historical data for product manufacture, analyzing data using statistical principles, writing validation protocols and reports, GDP review of data and reports, and final approval of validation protocols, reports, and deviations. May interact in cross-functional teams including Reagent Manufacturing Engineers and Chemists, Research and Development, and Quality Assurance Validation Engineers.

May be responsible for leading teams to perform validation activities or perform as a member of the team. Will simultaneously work 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)
• Acts as Quality Assurance reviewer/approver or author for validation protocols, reports, and deviations.
• Provides and applies quality engineering direction to projects using quality engineering and statistical principles.
• Root Cause Analysis
• FMEA
• Risk Management and Mitigation
• DOE
• Measurement Systems Analysis
• Sampling and Control Plans
• Post Market Surveillance Trend Review
• Process Capability
• Provides and applies scientific technical principles/concepts
• Follows company procedures
• Demonstrates working knowledge and application of applicable regulatory requirements
• Other duties as assigned.

• Education:
  
  bachelor’s degree

• Experience in a quality related function in a medical device or other FDA regulated environment. Previous work with IVD reagent products under GMP conditions
• Process validation (IQ, OQ, PQ) and test method validation experience
• Software validation experience
• Knowledge of general reagent manufacturing processes, antibody purification and conjugation, flow cytometry
• Certified Quality Engineer
• Six Sigma Certification
• Knowledge of applicable regulatory requirements including ISO
  13485, ISO
  14971, ISO
  9001, quality systems regulations (21 CFR: 820)
• Training in statistics.
• Experience with Minitab or other statistical software, MS Excel, and MS Word required

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