Validation Engineer

Santa Clara  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description

SUMMARY OF PURPOSE/FUNCTION:

The validation group is responsible for all aspects of validating the standard software platform including hotfixes, new releases, and customizations.

ESSENTIAL FUNCTIONS:
  • Assist with writing, reviewing and executing customer FATs, SATs and IOQs for a highly customizable software package. Completed under the direction of the Validation Manager.
  • Assist with writing validation tests for software customizations requested by customers. In general, this work is completed under an accelerated timeline.
  • Help develop and maintain SOPs.
  • Write validation summary reports.
  • Interact closely with customers for FATs.
  • Other Duties as assigned


ESSENTIAL SKILLS AND EXPERIENCE:
  • Validation experience: hands-on experience with the development and execution of FATs, SATs and IQ/OQs.
  • Strong knowledge of 21 CFR Part 11, GAMP, audit trails, security features, cGMP, GDP and regulatory requirements for automated systems.
  • Self-motivated and capable of adhering to strict deadlines is a must.
  • Highly effective verbal and written skills, including technical writing, are a must.
  • Ability to adapt the validation model in a rapidly changing environment
  • Flexibility to multi-task and develop innovative solutions


To find out more about Real please visit www.realstaffing.com
Start date
02/2014
From
Real Staffing
Published at
18.02.2014
Project ID:
664991
Contract type
Freelance
To apply to this project you must log in.
Register