Description
My client, a leading Medical Device company based in Limerick, have an immediate opening for an experienced Validation Engineer on a 6 month contract. This is an excellent contract opportunity during an exciting growth period for my client.Requirements
- Minimum 3-4 years experience as a Validation Engineer
- Automation experience
- Medical Device or Pharmaceutical industry experience
Responsibilities
- To control and manage the qualification documentation life cycle phases during the qualification phase and to facilitate the review
of these documents during the project.
- Prepare the hardware/process/software user requirements (URS) with engineers for the different cells on the line.
- Work with contract manufacturers in preparing and developing the Functional Design Specifications (FDS) and Detailed Design
Specifications (DDS) documentation.
- Co-ordinate qualification activities with contractors and vendors as required.
- Participate in Vendor Assessment Reviews and preparation of Vendor Assessment reports
- Preparation and review of dFMEA's and pFMEA's
- Preparation of the line Factory Acceptance Test (FAT) & Site Acceptance Test (SAT) documents.
- Support the FAT & SAT activities and executions
- Post execution reviews of all SATs and FATs for review and approval.
- Preparation of the IQ/OQ/PQ documents
- Preparation and review of Facilities acceptance test documents
- Prioritise qualification activities in line with the project schedule
- Create summary reports and to facilitate the review and approval of these documents
- Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports
- Create the Requirements Traceability Matrix (RTM) for the projects.
- Participate with other teams to develop a continuous improvement and learning culture
- Validation of HMI logins and eDHR logins were compliant with 21 CFR Part 11 for electronic signatures.
- Validation of traceability in user transactions within the eDHR database (SQL) were compliant with 21 CFR Part 11.
- Assist in audit preparation and participate in audit reviews
If you are interested in hearing more about this role then please apply directly or contact Derek Sheridan ASAP on to be considered for interview!
To find out more about Real please visit www.realstaffing.com