PharmEng Technology is currently looking for a Computer System Validation Specialist (CSV)
with strong experience in computer systems to join our team in Germany.
- Work with Technology Infrastructure team to ensure prerequisites are in place before starting site qualification activities.
- Enforce the use of the Qualification package being proposed by global.
- Facilitate and contribute to the completion of the Application FRA.
- Author Quality Plan/OQ/PQ, pre-approvals and post-approvals.
- Work closely with the site IT Head, Application Manager, SMEs and local eCompliance on the test cases and ensures no gaps between Application FRA and the written verification test cases before Quality Plan/OQ/PQ pre-approvals.
- Ensure local Change Requests are in place for this effort and are pre-approved before Quality Plan/OQ/PQ execution and updated/approved post Quality Plan/OQ/PQ execution.
- Work closely with the Program/local PMs to ensure delivery of documentation according to the program PDL.
- Lead the site tollgate checklists/report with the program PM.
- Coordinate Quality Plan/OQ/PQ Release approval forms for Non-GxP/GxP local applications with internal resources responsible.
- Drive completion/approval of deviations as they arise.
- Ensure SOPs are updated/approved to align with Go-Live for site if required.
- Qualification Report/Conclusion completion in the Quality Plan/OQ/PQ and final document approval.
- Provide additional support/knowledge transfer and help with upcoming migration activities at other sites as needed.
- Candidate must have highly technical background.
- 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/medical device 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).
- Ability to manage complex projects and timelines in a matrix team environment.
- Ability to independently identify compliance risks and escalate when necessary.