A leading bio-pharmaceutical 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 or cleaning validation. This is a new site within the global network to 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.
As Senior Engineer within the validation team you will be involved in front-end design through to installation liaising closely with on-site C&Q team as well as process engineering teams 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 Validation Manager; this position sits within a new team and this is one of the first roles to be hired into the group. Other responsibilities will include:
- Working closely within this team and liaising with multi-disciplinary teams on-site to deliver this start-up project; quality, supply-chain, manufacturing etc.
- Taking ownership of the process validation across upstream and downstream manufacturing operations
- Once established focus will shift to equipment optimisation and ensuring the most efficient ways of working are in place
- 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 network where required
- Supporting the resolution of production issues from a validation perspective
- 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
- Experience in a start-up green field or brown field project is highly desirable
- Ability to work well 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
- €65,000 - €70,000
- Annual performance-based bonus
- Personal healthcare
- Pension contribution program
- Life assurance
- Subsidised canteen
To discover more about this opportunity, apply now or contact Aisling Clements at HRM on +353 1 632 1883 for a confidential discussion.