Validation Manager

Validation Manager

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Position: Validation Manager

Location: Hercules, CA

Duration: Full time

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