PharmEng Technology is currently looking for a Computer System Validation Specialist (CSV) with strong experience in computer systems and software validation to join our team for a project in PA.
- 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 implement proprietary company software.
- 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.
- 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.