Validation Manager

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