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

We currently have an opportunity for a Validation Engineer within our Dungarvan team. Our Validation department is a fast paced, dynamic team that can give a host of opportunities to grow for the right candidate.   

The primary 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 audit. 

Job Responsibilities

• Operation and maintenance of the Exceptions and Incident Report systems.
• Co-ordinating the resolution of issues surrounding non-conforming work as necessary with Laboratory Management.
• Completion of internal audits.
• Operation and maintenance of the Audits module within Nautilus.
• Support the co-ordination and compilation of customer audit and regulatory inspection responses.
• Support the co-ordination and compilation of information for regulatory bodies as requested.
• Support the hosting of customer audits and regulatory inspections – point of audit set up, Quality Department representative during audits.
• Support the controlled drugs system – licences, procedures, legislation and compliance.
• Proposing and implementing improvements to the quality system in line with industry best practices and standards.
• General upkeep of the quality system through a plan of continuous improvement from CAPAs, audits, review of procedures and regulatory/legislation updates.
• Co-ordination of technical and quality agreements.
• Co-ordinating and submitting information to customers as requested – questionnaires, requests for regulatory information.
• Operation of the Supplier Approval system.
• Administration and control of external documentation including client methods and SMIS.
• Delivery of quality systems training as required.
• Assist in the preparation and delivery of the Annual Quality Review.
• QA approval of procedures and protocols.
• QA approval of certificates of analysis and technical reports.
• QA approval of Exceptions.
• Review and approval of calibration and qualification data as required.
• Assist in the maintenance of the ISO 9001 quality system.
• Deputise for the Senior Manager QA & PSS as requested in terms of review and approval of documentation and supervision of staff as necessary.

Experience / Skills

• At least 5 year’s experience in a laboratory or GMP regulated environment within a QA role is desirable.
• Working knowledge of pharmaceutical and ISO quality systems
• 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.
• Positive and tenacious approach to work.
• Highly organised, methodical and systematic approach to work.
• Passionate about quality and customer service.
• Good communication skills both internally and externally. Ability to understand customers’ requirements and to be able to devise and articulate the most appropriate solutions.

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 61,000 staff across a network of more than 1000 independent companies in over 61 countries and operating more than 900 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 2022, Eurofins generated total revenues of EUR € 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years