Job Description We have fantastic opportunity for a Validation Engineer to join our Quality team in Dungarvan Co Waterford.
The purpose of this 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 Responsibilities: Perform calibration, qualification, and preventative maintenance of equipment according to formal schedules, including completion of necessary documentation and labelling.
Manage and maintain calibration, qualification, and preventative maintenance schedules, including unscheduled activities and those following repairs or equipment movement.
Oversee equipment servicing and repair processes, including vendor communication, organisation of visits, and post-repair documentation and re-calibration.
Implement new equipment into service as per company protocols and maintain accurate equipment files.
Review and sign off external calibration certificates, generate internal certificates, and process external contractor information into the quality system.
Conduct rolling reviews of calibration, maintenance, and qualification Standard Operating Procedures (SOPs).
Ensure timely completion of exceptions, audit observations, change controls, and SOP periodic reviews, along with associated Corrective and Preventive Actions (CAPAs).
Maintain accurate, legible, and timely documentation in compliance with current Good Manufacturing Practice (cGMP) standards.
Take responsibility for personal training, keeping training records up-to-date, and initiating further training when workload permits.
Adhere to all company standards in safety, housekeeping, and quality, reporting any discrepancies to management.
Qualifications Education / Qualifications Primary degree or equivalent in Life Sciences or Engineering Minimum 3 years' validation experience in a GMP regulated environment, preferably with calibration experience Experience / Skills Strong knowledge of pharmaceutical processes for equipment calibration and validation Excellent communication, report writing, and organisational skills Quality-oriented with ability to work independently and in a team Experience in documenting analytical data and writing reports Passion for quality and customer service Additional Information 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 63,000 staff across a network of more than **** independent companies in over 60 countries and operating more than 950 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 ****, Eurofins generated total revenues of EUR € 6.95 billion, and has been among the best performing stocks in Europe over the past 20 years.