Leading biopharmaceutical CDMO are continuing to expand their Irish operation by establishing a new state-of-the-art facility in north Leinster. A vacancy has now arisen for an experienced Process Engineer with specialisation in either drug substance or drug product manufacturing technology. This site will manufacture for global supply and is in response to growing customer requirements. As this is the company's first site of this nature the engineering department will work closely with the global group to complete detailed doc design across processes and protocols as required.
If you are passionate about science, enjoy the challenge of working in a start-up environment and are ambitious this is a fantastic opportunity to join a rapidly expanding organisation.
As a team member you will work within the process & validation group. This is a challenging position and will require flexibility and creative approaches to problem solving.
- Reporting into the Head of Engineering this position is one of the first to be recruited into the new team which will expand over the coming months.
- You will work closely within this group and liaise with multi-disciplinary teams on-site to deliver effectively.
- Be involved with process design for manufacturing and support C & Q activities.
- Prepare required documentation, create SOP's and related change control processes and procedures.
- You will challenge equipment design specs and support the continued assessment of equipment performance across upstream/downstream process.
- Execute verification and validation protocols in collaboration with the CQV team as part of the start-up phase of this project.
- You will support the resolution of deviations; running investigations across equipment and process non-conformances, system failures and under-performance ensuring root cause analysis is completed, a solution is delivered, and corrective actions are implemented across systems and equipment.
- Support preparations for both internal and external audit readiness.
- Provide technical support and work to resolve manufacturing issues from a process perspective.
- All applications must have a Degree in Engineering with a minimum of 4 years' experience within a manufacturing environment.
- The right person will have experience within a highly regulated GMP manufacturing operation.
- A strong communicator with the ability to work well within a cross-functional team to achieve a common objective.
- Collaborative approach to work and a positive attitude will be a good fit with this team dynamic.
- Be autonomous in your approach to work and an effective communicator.
- Competitive salary
- Annual performance-based bonus - 9%
- Personal healthcare plan
- Pension contribution program
- Life assurance
- 22 days annual leave
- Parking on-site
- 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.