Position: Validation Manager
Location: Hercules, CA
Duration: Full time
Job Description
Lead Engineering Verification and Validation Activities managing a small contingent of validation engineers.
• Serve as Subject Matter Expert (SME) for all verification and validation activities
• Develop and oversee verification protocols to verify engineering specifications
• Develop and oversee validation protocols to validate customer requirements
• Analyze verification and validation test data
• Document test protocols and reports
• Support Root Cause Analyses and Develop Corrective Measures
o Conduct root cause analysis using test data and/or field failure data
o Develop and verify/validate effective countermeasures against root cause(s) of failure
• Support Reliability Improvement Projects
o Apply methodologies to drive reliability improvements
o Develop and execute reliability test methods
• Support Change Control Process
• Support Engineering Design Reviews
Required Skills
• An understanding/working knowledge of Fluidics/Filling Operations, Automation, Robotics, Cold Storage, Packaging, and site validation. DI Water Systems
• Highly proficient in the use of MS Office Suite (Word, Excel, Power-point, Project)
• Proficient in the use of Minitab and/or other statistical analysis software
• Excellent written and verbal communication skills
• Ability to work effectively in teams – cross-functionally and within engineering
• Ability to multitask effectively and efficiently
• Ability to work effectively with general direction
• Highly capable of independent and critical thought and action
Required Experience
• BS/MS in an Engineering discipline or Physical Sciences
• Six Sigma Green Belt (preferred)
• Test Implementation, Verification & Validation, and Risk Assessment
• Root Cause Analysis, Development of Corrective Actions
• Hands on application of Statistical Analysis
• Working knowledge of FDA regulatory requirements and all internal quality standards
• 5-7 years of experience in medical device validation/FDA regulated industry.
• 3-5 years of management leadership experience
• Project planning skills