Temporary CSV Engineer
Job Description
Overview
A Computerized System Validation (CSV) Engineer required for a 6-12 month contract position in the west of Ireland in a regulated medical device site.
Responsible for writing all validation documents and executing validation protocols for a new data warehouse system in compliance with current Good Manufacturing Practices (cGMPs) and all other regulatory and/or guidance requirements particularly 21 CFR Part 11.
Provide validation and GDP support to parallel project on site.
Responsibilities
The main responsibilities of this position include, but are not limited to:
Conduct validation activities in compliance with US, EU regulations and GAMP 5 methodology
Carry out all necessary assessments for compliance with applicable regulatory standards.
Advise the project team on the security requirements of 21CFR part 11
Advise the project tem on data retention, data integrity, data backup, data restore requirements of 21CFR11
Develop validation documentation as required – at a minimum:
Validation Plan
Risk Assessments (Assist with delivery of FMEA)
User Requirements Specifications
Configuration Specification
Identify a modular testing strategy and define in a test plan
Prepare the required protocols: IQ, OQ and PQ
Requirements Traceability Matrix
Validation Summary Report
Prepare reports of executed protocols for review by QA.
Coordinate qualification document review and approval.
Review and approve all validation and quality documents prepared by the validation team.
Execute qualification protocols as required and coordinate qualification activities in line with the project schedule
Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
Prepare and / or support the creation of system operation and administration SOPs
Requirements
Third level qualification in Engineering, Science and/or related discipline.
Degree qualification in science or engineering is desirable.
Experienced in the validation of SQL server systems with web access.
Proven experience in the validation of computerized systems in FDA regulated industry
Customer focus.
Attention to detail.
Good problem solving skills.
Results and performance driven.
Adaptable and flexible.
Excellent communication skills both written and verbal.
Ability to operate as part of a team is critical.
Ability to work alone as required.
How to Apply
Email CVs to recruitment@gxpsystems.com2908 total views, 2 today