Validation Manager

Integrated Resources Inc.; Hercules (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

A premier staffing firm seeks a Validation Manager to lead verification and validation activities in Hercules, CA. The role demands expertise in engineering principles and FDA requirements, with a focus on improving reliability and developing effective countermeasures. Ideal candidates will hold a BS/MS in Engineering and possess extensive experience in the medical device industry.

Qualifications

• Hands-on experience in validation and FDA regulations.
• 5-7 years in medical device validation.
• Management experience of 3-5 years.

Responsibilities

• Lead Engineering Verification and Validation Activities.
• Develop and oversee verification and validation protocols.
• Analyze verification and validation test data.

Skills

Fluidics/Filling Operations

Automation

Robotics

Cold Storage

Packaging

MS Office Suite

Minitab

Communication Skills

Teamwork

Multitasking

Education

BS/MS in Engineering or Physical Sciences

Tools

Minitab

Statistical Analysis Software

Job description

A Few Words About UsIntegrated 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

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

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

• 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

Qualifications

• BS/MS in an Engineering discipline or Physical Sciences