Consider joining Eurofins where people are the most important element in our business. Eurofins Biopharma Product Testing is a leading contract lab that provides testing and research services in the environmental, pharmaceutical, and biopharmaceutical sciences to clients worldwide.
We have a fantastic opportunity for a Validation Engineer to join our Quality team in Dungarvan Co Waterford.
The purpose of this role is to execute the Metrology schedule and Metrology helpdesk activity required to support the Operations function, operating at the highest quality and productivity standards, ensuring agreed internal client requirements are entirely satisfied and that client expectations are met or exceeded. This person will be a key point of contact for all Metrology activities on a day-to-day basis, including external audits.
Job Description
Job Responsibilities
* Calibration and qualification of equipment as per formal schedule including completion and filing of documentation, labels and application of labels.
* Maintain the Metrology Helpdesk generating reports & metrics and completing own assignments.
* Calibration of equipment - unscheduled, following repair or movement. Completion of documentation, labels and application. Completion of Preventative Maintenance documentation, filing of service reports.
* Working of the Preventative Maintenance system i.e. documentation, issuing of log books, updating schedule according to changes, obtaining signatures, re-calibration where necessary.
* Servicing and repair: quotes and details, correspondence with vendors, organisation of vendor visits or despatching equipment where necessary, documentation following completion of repair and re-calibration.
* Maintenance of schedules: Calibration, Qualification, Preventative Maintenance.
* Putting new equipment into service as per ELL protocol for acquisition of new equipment.
* Checking and signing off external certificates of calibration and generating internal certificates for same.
* Gathering information of external contractors, qualifications, procedures etc. and processing into the quality system.
* Organisation and maintenance of equipment files.
* Rolling review of calibration, maintenance and qualification SOPs.
* Assist the Computer Systems Validation team as required.
Qualifications
Education / Qualifications
* Primary degree or equivalent in related discipline (Life Sciences, engineering).
* At least 3 years’ validation experience in a laboratory or GMP regulated environment is desirable; preferably with calibration experience.
Experience / Skills
* Previous experience in GMP regulated Environment.
* Awareness of pharmaceutical processes for equipment calibration and validation.
* Ability to work independently or as part of a team.
* Excellent report writing, communication and organisational skills.
* Quality oriented with the ability to consistently work to industry and client standards.
* Experience with documenting analytical data and writing reports.
* Passionate about quality and customer service.
* Good communication skills both internally and externally.
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