Validation Consultant

ID# DCPA26879

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

Responsibles 

  • Responsible for the authoring and execution of all Computer System Validation deliverables related to the client's base business. 
  • The Tech Ops CSV Engineer will also be responsible to manage external computer system validation resources ensuring delivery to project schedules. 
  • Conduct systems assessments in accordance to a defined protocol. 
  • Author remediation plans based on identified gaps. Develop & execute application specific Validation Strategies. 
  • Author/Manage all CSV deliverables in accordance with applicable policies related to I/T SDLC, site QA procedures and regulatory requirements. 
  • Manage validation testing activities and document management and control of validation deliverables during the project phase and system maintenance. 

Qualification 

  • A minimum of a Bachelor's Degree in Science and/or Engineering is required. Must have at least Five (5) years of related business and IT experience in the Pharmaceutical industry. 
  • Experience working with SDLC methodology, 21 CFR Part 11, GxP is required. Knowledge of CSV frameworks, GAMP and manufacturing control systems is preferred. 
  • Ability to work independently and manage multi-projects is required. 
  • Experience authoring and executing validation protocols and SOPs is preferred. 
  • Ability to communicate verbally and in writing with all levels of organization. 
  • Able to support other departments and/or projects according to business needs.

Position Details:

Consumer Product

Engineering

Start Date: 
9-2-2013
End Date: 
9-9-2014

LANCASTER, PA

Full Time

1965

DCPA26879

No

No