Working in their state of the art Laboratories, the Lab Systems Engineer will be responsible for Validating varied systems and bench top analytically equipment
Key Duties are as follows:
- 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.
Please apply now with you CV to be considered for this long-term opportunity.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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