We are seeking applications for an experienced QC Lab Support Validation Engineer to support our client’s state of the art Bulk Drug Substance manufacturing facility’s QC Laboratory in Dublin.
 
Why you should apply:

• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

 
What you will be doing:

• 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.

• Degree in a software or engineering related discipline or Degree in chemistry or biological science
• 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.