Validation Engineer

  • Full-time

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Consider joining Eurofins where people are the most important element in our business.  Eurofins is a leading contract lab providing testing and research services in the environmental, pharmaceutical, and biosciences to clients worldwide.

 

Eurofins Laboratories is currently recruiting a Validation Engineer for our Laboratory based in Dungarvan Co Waterford.

 

The primary purpose of this role is to execute the Validation schedule and helpdesk activity required to support the Operations function at ELL, 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 Validation activities on a day-to-day basis, including external audits.

Job Responsibilities

 

  • Calibration, Installation, Operation & Performance qualification (IOPQ) of Laboratory (Direct/indirect) equipment as per formal schedule including completion and filing of documentation, labels and application of labels.
  • Maintenance of schedules: Calibration, Qualification, Preventative Maintenance & re-qualification of equipment.
  • 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.
  • 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.
  • Installation, Operation & Performance qualification (IOPQ) of new equipment into service as per ELL Validation protocol for acquisition of new equipment.
  • Checking and signing off external certificates of calibration and generation internal certificates for same.
  • Gathering information of external contractors, qualifications, procedures etc. and processing into the quality system.
  • Periodic review of calibration, maintenance and qualification SOPs.
  • Ensure Exceptions, internal audit observations; external audit observation, change control, and SOP periodic review are performed by you on time along with associated CAPAs.
  • This person will ensure that all documentation is carried out on time, is accurate and legible and conforms to cGMP.
  • They are responsible for their training, keeping their training sheets up to date and initiating   
    training where possible when free from work.
  • Responsible for adhering to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.
  • As with all members of staff in ELL this person is responsible for ensuring that customers’ requirements are fully met and in so doing will be flexible to work in any area of the business as is required.

 

Experience/Qualifications

 

·        Primary degree or equivalent in related discipline (Life Sciences, engineering)

·        At least 1-5 years’ experience in a laboratory or GMP regulated environment is desirable; preferably with Calibration/Validation experience.

·        Previous experience in GMP regulated environment.

·        Awareness of pharmaceutical processes for equipment calibration and validation.

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