Validation Specialist

Linde•Morrisville, PA
•Onsite

About The Position

The Validation Specialist will manage the overall validation program for all LG&E operations and systems. This role will support all locations with executing validation protocols and interface extensively with all LG&E locations, Linde Quality, R&D, Safety, and Healthcare personnel. The specialist will assist Linde Gas & Equipment Inc. and Linde Canada plant Operations in the execution of Process Validation and Analytical Method Site Qualifications in conjunction with New Plant Commissioning, New Plant Processes and New Analytical Methods by directing the work and analyzing the results to provide continuous improvement. The role involves assessing validation performance using statistical methods, developing analytical method protocols, Site Qualification studies, and analyzer operating methods. Additionally, the specialist will develop training programs for new analyzers and serve as a resource to Quality and Corporate Assessment teams on Validation Matters, as well as train and coach Location Validation Teams.

Requirements

  • Bachelor’s/Associate Degree in a Science/Engineering or related technical field
  • Strong communication skills
  • Organizational agility
  • Solid organizational skills
  • Good Laboratory Practices with emphasis on Gas Specific analyzers and methods including Gas Chromatography
  • Packaged Gas Production Operations
  • Knowledge of Process and Analytical Method Validation Principles
  • Knowledge of Quality Management System Principles

Responsibilities

  • Manage the overall validation program for all LG&E operations and systems
  • Support all locations with executing validation protocols
  • Interface extensively with all LG&E locations, Linde Quality, R&D, Safety, and Healthcare personnel
  • Assist Linde Gas & Equipment Inc. and Linde Canada plant Operations in the execution of Process Validation and Analytical Method Site Qualifications
  • Direct work and analyze results for continuous improvement
  • Assess validation performance using statistical methods
  • Develop analytical method protocols, Site Qualification studies and analyzer operating methods
  • Develop training programs for new analyzers
  • Be a resource to Quality and Corporate Assessment teams on Validation Matters
  • Train and coach Location Validation Teams

Benefits

  • Health insurance
  • Dental insurance
  • Disability insurance
  • Life insurance
  • Paid holidays
  • Vacation
  • Employee discount program
  • Opportunities for educational and professional growth
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