Lab CSV Engineer
This is a contract role in a well-known, multinational Pharmaceutical Manufacturing site based in Dublin. The Lab CSV Engineer will work with internal and external teams to ensure equipment compliance with cGMP, perform CSV functions, create and maintain equipment validation plans and assist laboratory personnel to improve workflows.
- Evaluate systems/equipment in accordance with cGMPs, Part 11, and other regulatory requirements.
- Input and define User Requirement specifications.
- Working closely with user groups to evaluate, develop, implement, and maintain laboratory equipment and systems.
- To work with laboratory personnel to improve processes, streamline workflow, and increase productivity in laboratory operation.
- Planning, executing, and documenting the qualification of new laboratory equipment in a cGMP regulated environment.
- Developing and maintaining an equipment qualification project plan, as part of the commissioning of new laboratory facilities.
- Writing wraparound IQ/OQ and PQ equipment validation protocols and associated reports.
- Accompany vendors and ensure that all documentation is completed prior to and during vendor service engineer site visits when performing routine calibration, qualification, requalification and/or preventative maintenance activities in the QC laboratory.
- Generation and resolution of protocol discrepancies and deviations that arise as required.
- A minimum of 4 years’ experience in a similar role.
- Subject matter expert for CSV Computer systems validation.
- In-depth knowledge of Annex 11 and CFR Part 11 requirements.
- Experience at executing validation, data management and data integrity.
- Knowledge of the methodology, instrumentation and analytical techniques used for biopharmaceutical testing.
- In-depth understanding of current regulatory requirements for cGMP laboratory equipment validation.
- Degree in a software or engineering related discipline, or a Degree in chemistry or biological science.
Milestone Solutions is a dedicated consultancy providing industry solutions to the Life Sciences, Discrete Manufacturing, FMCG and Chemical Processing industries; for more information go to www.mile.ie
If you would like to discuss this opportunity or your career options in more detail, please contact Lisa Cooney on +353 83 337 1056 or send your CV to email@example.com