QC Lab Validation Engineer
- NI & Ireland
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
As Dublin continues to embed itself as Ireland's Pharmaceutical capital, we are seeking a QC Lab Validation Engineer to become part of a $500 million state of the art bio facility.
Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation leads the way with state of the art technology on their one of a kind manufacturing facility.
Essential Duties and Responsibilities for this QC Lab Validation Engineer role include, but are not limited to, the following:
- As the QC Lab Validation Engineer you will be responsible for evaluating Systems and/or Equipment in accordance with cGMPs, Part 11 and other Regulatory requirements.
- The QC Lab Validation Engineer will work closely with user groups to evaluate, develop, implement and maintain Laboratory Equipment and Systems.
- You will improve processes, streamline work-flow and increase productivity in Laboratory operation and also plan, execute and document the Qualification of new Laboratory Equipment.
- The QC Lab Validation Engineer will write wraparound IQ/OQ/PQ Equipment Validation Protocols and associated reports.
- You will accompany vendors and ensure that all documentation is completed prior to and during vendor service engineer site visits when performing routine Calibration, Qualification, Re-qualification and Preventative Maintenance activities in the QC Laboratory.
- As the QC Lab Validation Engineer you will be qualified to degree level in Software, Engineering, Chemistry or Biological discipline and have a minimum of 3 years’ experience.
- The QC Lab Validation Engineer will be a Subject Matter expert for Computer Systems Validation.
- You will have strong experience at executing Validation, Data Management and Data Integrity and an in-depth knowledge of Annex 11 and CFR Part 11.
- The QC Lab Validation Engineer will have excellent knowledge of Methodology, Instrumentation and Analytical Techniques used for Biopharmaceutical Testing.
The candidate must have the rights to work in the location stated in the job advert.
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We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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