A leading biopharmaceutical organisation who are establishing a new state-of-the-art facility in North Leinster are looking for an experienced Validation Engineer with specialisation in either process equipment or cleaning validation. This is a new site within the network to support niche customer requirements and will supply product into global markets. As this is the company's first site of this nature the engineering department will work closely with the global group to complete detailed design and all other processes and protocols as required. The company currently employs over 3,000 staff globally across their biologics business operations spanning Europe, Asia and the US.

The Role

As a Senior Engineer within the manufacturing technology team, you will be responsible for process validation activities on-site. This position will liaise closely with the C&Q, manufacturing, supply chain and quality teams as well as working with the process engineering group on-site to ensure they manage full validation processes effectively. This is a challenging position and will require flexibility and a creative approach to problem solving. Reporting into the head of Manufacturing Technology; this position sits within a new team and is one of the first roles to be hired into the group.

Other responsibilities will include:

• Working closely within this technical group and liaising with multi-disciplinary teams on-site to deliver this start-up project, quality, engineering, supply chain & manufacturing
• Taking ownership of the process validation across upstream and downstream manufacturing operations
• Design and oversee product transfer strategies for the site
• Challenging the design as required and managing the delivery of external suppliers into the project, maintaining integrity of design and regulatory requirements throughout
• Collaborating closely with external manufacturing partners and affiliates within the company's global network
• Supporting the resolution of production issues from a validation perspective
• Investigating deviations and identify resolutions in a timely manner
• Once established focus will shift to equipment optimisation and ensuring the most efficient ways of working are in place

The Person

• All applications must have a degree in Engineering with a minimum of 5 years' experience within a manufacturing environment leading a team operationally or within a project
• The right person will have experience within a highly regulated GMP manufacturing operation preferably biological/biotech background - specifically drug product
• Versed in troubleshooting and investigating deviations
• Experience in a start-up green field or brown field project is highly desirable
• Ability to work effectively within a cross-functional team to achieve a common objective
• Be collaborative in your approach to work and an effective communicator
• Engage cross functionally to deliver on process improvement projects in conjunction with a site-based team

The Benefits

• €65,000 - €75,000
• Annual performance-based bonus
• Personal healthcare insurance
• Pension contribution program
• Life assurance
• Parking on-site
• Subsidised canteen

To discover more about this opportunity, apply now or contact Aisling Clements at HRM on +353 87 7521041 for a confidential discussion.