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Computer System Validation Specialist

Atlanta, GA
PharmEng Technology is currently looking for a Computer System Validation Specialist with strong experience in computer systems and software validation to join our team for a project in Atlanta, GA.

Job Description:
  • Preparation of Validation protocols for GxP critical reports.
  • Assist in protocol execution, review and approval.
  • Generation of Change requests and IT tickets for the validation of reports.
  • Validation of business intelligence reports and skilled with all the tests required to properly qualify the reports.
  • Review existing SOPs and prepare draft to serve as the framework for Computer System Validation Projects.
  • Develop and execute documentation for validation and qualification activities to support various computer system validation projects. Documents to be authored may include URS, FRS, FRA, HLCCD, etc.
  • Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control, etc.
  • Ensure compliance of computerized systems to relevant regulatory requirements (e.g. cGMP/GLP/GAMP/GALP).
  • Draft templates for High level Risk Assessments, User Requirements Specification, Validation Plan and Validation Summary Reports.  Prepare Validation Plans, IQ, OQ, Validation Summary Reports.
  • Acts as liaison between Quality Assurance and project team to assure that GxP software is implemented in compliance with applicable regulations and guidelines.
  • Attend meetings to assist in the development of a validation remediation strategy.
  • This project will include mechanical, controls and software modifications in regards to the air compressor units.

Minimum Requirements:
  • Bachelor’s degree in business/technical area or comparable education/experience 
  • A minimum of 5 years’ experience in Computer Systems Validation within the pharmaceutical/biotechnology GMP environment including authoring and execution of IOQ/PQ’s, experience in performing traceability matrices, risk assessments 
  • Solid understanding of Computer Systems Validation of Manufacturing and Packaging systems
  • Working knowledge of regulations, such as 21CFR Part 11, Good Automated Manufacturing Practice (GAMP5), GLP and Good Automated Laboratory Practice (GALP) 
  • Must have strong hands-on, end-to-end CSV project experience and application of project controls - including familiarity with all project lifecycle phases from requirement gathering through delivery, issues/risk management, change management, release management. 
  • Solid understanding of data integrity risks
  • Ability to manage complex projects and timelines in a matrix team environment 
  • Ability to independently identify compliance risks and escalate when necessary
 
 
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