Validation Specialist

Norristown, Pennsylvania 19401

Post Date: 04/16/2018 Job ID: 5955 Industry: Other Area(s)

McGrath Systems is currently accepting application for a direct hire Validation Specialist to work in the Norristown, PA area

Responsibilities:
  • Responsible for defending site and company validation policies/practices in front of regulatory agencies during inspections and regulatory submissions.
  • Identify validation improvement initiatives for alignment with current validation best practices.
  • Generate and approve validation assessment for new or existing changes to sterilization equipment, utilities and processes.
  • Interface with global validation group to ensure sterilization validation practices
  • Complete gap assessments for global guidance and perform remediation activities to ensure site compliance.
  • Support site IPTs during investigations and troubleshooting as a thermal validation/sterilization subject matter expert.
  • Support new or existing product regulatory filing requirement and provide subject matter expertise review throughout the process.
  • Provide support to obtain accurate and real time site validation metric to maintain the health validation compliance.
  • Identify validation improvement initiatives for alignment with current validation best practices.
  • Manage internal/external, indirect/direct validation scientist/contractors as needed based on the sterilization project needs.

 

Education Minimum Requirement:  
  • BS,  Preferably in Engineering or Sciences

 

Required Experience and Skills:
  • Minimum of 10 years relevant work experience, hands on experience on validation activities on sterile products manufacturing and/or laboratory operations.
  • Strong knowledge and hands on experience Sterilization, Depyrogenation, VHP, Radiation,  Sterilization in place and sterilizer equipment.
  • Experience interacting with regulatory agencies.
  • Demonstrate strong knowledge on different types of sterilization concepts such as but not limited to: D-Value, Lethality, SAL, Biological indicator and exposure time.
  • Strong communication, collaboration skills and ability to drive accountability
  • Strong background solving analytical and/or complex problems.
  • Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).
  • Experience coaching validation contractor(s) and/or direct reports
  • Strong knowledge and hands on experience interpreting guidances/guidelines for sterilization such as but not limited to; BS EN 285, ISO, USP, PDA and AAMI for different types of sterilization.

 

Preferred Experience and Skills:
  • Minimum of 7 years work experience on different areas of sterilization.
  • Master Degree in Science or Engineering Related Degree
  • Experience with Risk-Based Approach to Commissioning and Qualification.
  • Strong experience working on cross-functional team to achieve common goal.
  • Experience writing validation assessment and white paper for sterilization.

 

McGrath Systems is an Equal Opportunity Employer and embraces diversity in the workplace.

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