About Aerogen:
Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and eleventh-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients lives every day, having already reached 20 million patients in over 80 countries.
Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care.
Our business is growing rapidly across the globe and as we grow, our core culture of We Care universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discoverbetter.
What is the role?
The Process Engineer I is responsible for supporting process optimization and quality control initiatives. They will analyze production data and collaborate with engineers to identify and troubleshoot process issues. They will assist in the implementation of improved procedures and contribute to the development of efficient production processes by ensuring adherence to quality standards and production protocols.
What are the key responsibilities?
* Support the analysis of production data to identify trends, deviations, and potential areas for process improvement.
* Collaborate with engineers to troubleshoot process issues, contributing to root cause analysis and proposing solutions.
* Assist in the implementation of improved procedures and ensure adherence to established quality control protocols.
* Participate in process audits and document findings to maintain accurate quality control records.
* Assist in developing new or improved process documentation, including standard operating procedures (SOPs) and flowcharts.
* Conduct research on industry best practices and new technologies to identify potential applications for process improvement.
* Contribute to pilot projects for testing and evaluating new process modifications.
* Maintain awareness of relevant industry standards and regulations to ensure process compliance.
* Effectively communicate process data and findings to engineers and other team members.
* Actively participate in team meetings and discussions, seeking guidance and learning from experienced engineers.
* Maintain clear and concise documentation of processes, procedures, and troubleshooting efforts.
* Assist with basic equipment maintenance and calibration tasks.
* Perform data entry and analysis tasks to support process monitoring and control.
* Contribute to the development and implementation of preventative maintenance plans
* Perform other assigned tasks as directed by Manager or Head of Function.
What education and experience are required?
* A minimum of Level 8 degree in a relevant discipline
* 1-3 years of relevant experience
What key skills will make you great at the role?
* Technical Ability - Understands engineering principles theories and is able to complete technical activities. Experienced working in teams to support design, development, validation and troubleshooting of equipment and processes within manufacturing environment.
* Problem-Solving capability: you can conduct root cause analysis by applying problem solving methodology and support the development of potential solutions to achieve improvements.
* Ability to analyze production data to identify trends, deviations, and potential problems.
* Collaboration: Effective communication and interpersonal skills; written, verbal and presentation and able to work well with others.
* Experience working in medical device manufacturing, maintaining, and improving processes with good understanding of EN ISO 13485:2016, EU-MDR, MDSAP and FDA requirements as these apply to this role.
* Knowledge of design verification and process validations, with focus on equipment / manufacturing processes.
* Ability to develop and implement improved process procedures with cross functional approval.
* Attention to detail and ability to follow established protocols for quality control.
* Excellent written and verbal communication skills to effectively present data and findings to engineers and other team members.
* Strong work ethic, initiative, and willingness to learn, with ability to work independently while also collaborating effectively as part of a team.
What is it like to work at Aerogen?
Our purpose is to transform patient lives and our ethos is to #discoverbetter. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits. Theres something for everyone Here is an idea of what we offer:
* Excellent medical care.
* Bonus & Pension.
* Aerogen Connect our employee led programme which supports our global teams to unite and have fun.
* We pledge 1% of profits and time to charities and organisations. Visit our careers website for more information about life at Aerogen.
Aerogen is committed to promoting diversity, inclusion, and equality in the workplace. If you have difficulty using our application process, please contact us via email at Please provide your name and preferred contact method.