Description
A global Pharmaceutical Organisation is currently looking for a QC Lab Support Validation Engineer to join their team for a range of large-scale projects in Ireland.The responsibilities of the QC Lab Support Validation Engineer will include:
- Evaluate systems/equipment in accordance with cGMPs, Part 11 & other regulatory requirements.
- Establish working knowledge with regards to regulatory requirements for equipment qualifications and calibration.
- Work closely with user groups to evaluate, develop, implement & maintain systems to improve process, streamline workflow and generally increase productivity in lab operations.
- Planning, executing and documenting the qualification of anew lab equipment in cGMP regulated environment.
- Minimum of 2 years of laboratory experience in a cGMP laboratory and instrument validation experience is desirable.
- Knowledge of the methodology and instrumentation and analytical techniques used for biopharmaceutical testing.
- In depth understanding of current regulatory requirements for cGMP laboratory equipment validation.
- Excellent technical competency in the field of instrumentation and equipment validation.
- Skilled in organisation, planning, priority setting and time management.