Description

The primary focus of the Quality Specialist Engineer will be to support GMP operations by providing expert oversight and guidance on investigations, change controls, and compliance activities, ensuring adherence to regulatory standards and fostering continuous improvement within the maintenance and engineering functions.

Job Responsibilities:

• Provide oversight and expert guidance on investigations related to Maintenance/Engineering activities and the administration of Change Controls.
• Ensure strict adherence to GMP standards across all Maintenance/Engineering operations within designated areas.
• Review and assess change control documentation and failure investigation reports pertinent to Maintenance/Engineering functions.
• Identify, document, and escalate significant non-conformances to appropriate management for timely resolution.
• Conduct thorough reviews of key GMP documentation, including standard operating procedures, relevant to Maintenance/Engineering responsibilities.
• Facilitate effective communication and deliver training to personnel on GMP regulations and compliance requirements related to Maintenance/Engineering.
• Execute daily operational activities in compliance with site safety policies and procedures.
• Provide coaching and technical support to Maintenance/Engineering team members in the execution of investigations and Change Control processes.
• Review and evaluate change controls, deviations, and failure investigations associated with Maintenance/Engineering activities.
• Collaborate with cross-functional teams to promote continuous improvement in GMP compliance and operational excellence.
• Maintain comprehensive and accurate records of investigations, deviations, and change controls to ensure audit readiness.
• Support the implementation of corrective and preventive actions derived from investigation outcomes.
• Stay informed on current regulatory requirements and industry best practices related to Maintenance/Engineering within a GMP environment.

Qualifications

• BSc, Biotech, Chemistry, Engineering or related discipline, with a minimum of 3 years relevant experience.
• Dedicated to meeting the expectations and requirements of internal and external customers.
• Builds a customer-centric focus within the organization by ensuring that internal processes are designed with the customer in mind
• Gets first hand customer information and uses it for improvements in services and products.
• Understands customers’ concerns and critical problems, and demonstrates that solving their problems is a top priority
• -Works to meet business goals set by management (e.g., manages to a budget, meets sales quotas, on-time delivery, quality requirements, key business metrics)
• Takes numerous, sustained actions over time in the face of obstacles to reach growth goal(s)
• Works towards implicit standards of excellence in the pursuit of growth
• Knows and utilizes the theories and practices that are required to succeed.
• Understands and is clearly able to describe work processes to others.
• Familiarity with how other department functions relate to the job
• Active listeners who consistently checks for understanding
• Builds good working relationships with others
• Exhibits appropriate behaviour and language at all times on job or at company events
• Gains cooperation of others to improve performance of self and others
• Maintains confidentiality of company or personal information of others.
• Places high value on workplace safety of self and others
• Attends and participates in safety meetings
• Identifies potential hazards and pursues corrective actions
• Maintains a clean and organized work area and environment

Additional Info

*This is an opportunity to join Eurofins on a full time permanent basis,  working 39 hours per week Monday - Friday.

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 47,000 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 2024, Eurofins generated total revenues of EUR €6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.

Company Description

 ****We have an opportunity for a full time permanent Quality  Specialist Engineer to join our PSS Site in Ringaskiddy****

Consider joining Eurofins PSS® where people are the most important element in our business.  Eurofins PSS® is the global leader of scientific insourcing services. PSS® is not only a leader in the industry, but also one of the first insourcing service providers, now celebrating over 15 years of service in Ireland and over 22 years of service globally.

For more information about Eurofins PSS® please visit our website and watch a message from our Global Head, Beth Di Paolo.

We currently have exciting opportunities to join our innovative and multi award-winning Professional Scientific Services (PSS) teams. The excellent service provided via our PSS model is delivered while maintaining the same commitment to excellence, expertise and cGMP compliance available at our Eurofins facilities.

What can Eurofins offer you as an employee of ours?

• Developmental opportunities and career progression
• The opportunity to work with our client - a world -leading pharmaceutical and biotechnology company
• Location is easily accessible
• Private Medical Insurance
• Income protection and life assurance
• Annual discretionary bonus
• Free parking onsite
• Full use of the canteen facilities on the client site
• Additional annual leave days with continued service
• The opportunity to work on products helping to save lives across the world.