Validation Engineer
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 63000 staff across a network of more than 1000 independent companies in over 60 countries and operating more than 950 laboratories. Eurofins offers a portfolio of over 200000 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 2024 Eurofins generated total revenues of EUR 6.95 billion and has been among the best performing stocks in Europe over the past 20 years.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
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 the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more
