Leading pharmaceutical company is looking for a CSV Engineer on permanent basis. Reporting to the relevant Lead, this position will have a significant role in the validation of computerized system.
100% remote work initially but will be required onsite as time goes by.
- Developing and executes all validation deliverables
- Owning issues/deviations and driving them to resolution.
- Leading testing efforts for small to medium sized projects.
- Reviewing vendor protocols, test scripts, and traceability matrix.
- Generating test scripts to meet the user requirements.
- Interacting directly with project teams and the associated vendors.
- Assessing the validation impact of changes made to qualified instruments.
- Other duties as assigned.
Job Skills & Experience Required
- 5+ years’ experience in Bio-Pharmaceutical
- Computer Science or Engineering/Science Degree is preferred.
- Experience working in a QC Lab Environment.
- A thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 / Annex 11 requirements.
- A thorough understanding of current industry guidance, including GAMP 5
- Direct experience with computer validation and determining computer validation approach.
- Experience/Knowledge in qualifying DeltaV, OSI PI, Serialisation changes.
- Experience with HP ALM or equivalent software testing/requirements tools.
For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / firstname.lastname@example.org
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