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 eight-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 person in this role is responsible for developing, improving and implementing new processes and technologies used to manufacture Aerogen products to support Aerogen's long term growth and ambition plans. You will have a strong data-driven mindset and problem-solving capability with the ability to identify creative and innovative solutions. You will embrace change and work collaboratively with others.
What are the key responsibilities?
1. Design, generate and execute test plans and test protocols ensuring validation documentation is fully compliant with site specific policies/procedures and regulations, good manufacturing practices and industry regulations.
2. Lead project teams or work as part of an overall project team on specific assignment objectives.
3. Lead the introduction of new Products and Process technology through Process Development and Validation.
4. Identify innovative new processes and equipment to support Aerogen's product portfolio and process optimization.
5. Work with external vendors and suppliers to support improving Aerogen processes and manufacturing capabilities.
6. Design, generate and execute process and equipment validations including DV, URS, FAT, SAT, IQ, OQ, PQ, PPQ protocol development, implementation, and report completion to timelines.
7. Lead troubleshooting of equipment and process issues utilizing lean troubleshooting, preventative maintenance, and design methodologies.
8. Collaborate with and communicate effectively to the R&D, manufacturing, operations, quality, sales and marketing functions through the product development lifecycle.
9. Mentor and be responsible for activities and training of other team members.
10. Be involved in continuous improvements to how the PD team operates.
11. Act as a role model for Aerogen's We Care Cultures and Values program within the PD team.
12. Perform other assigned tasks as directed by Manager or Head of Function.
What education and experience are required?
1. A minimum of Level 8 degree in a relevant STEM discipline.
2. 4-6 years of relevant experience.
What key skills will make you great at the role?
1. Technical Experience: Experience of design, development, validation and troubleshooting of equipment and processes within manufacturing environment with SME expertise in applicable areas and able to mentor and coach others.
2. Problem-Solving capability: You can conduct root cause analysis and experiments by applying problem-solving methodology and support the development of potential solutions to achieve improvements.
3. Data analysis: You seek and analyse data and present it in a logical way that others can take action with a strong attention to detail.
4. Project Planning: You can execute and manage project deliverables by planning, monitoring, adjusting, and communicating project activities.
5. Collaboration: Effective communication and interpersonal skills; written, verbal and presentation. Identifies and addresses roadblocks in a respectful and accountable way.
6. 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.
7. Highly motivated self-starter and able to work in a dynamic environment with little supervision or daily direction.
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. There's something for everyone! Here is an idea of what we offer:
1. Excellent medical care.
2. Bonus & Pension.
3. Aerogen Connect our employee-led programme which supports our global teams to unite and have fun.
4. We pledge 1% of profits and time to charities and organisations.
Check out our careers website to discover more about Life at Aerogen.
Aerogen is committed to promoting diversity, inclusion and equality in the workplace. If you have any difficulty using our application process, please contact us by emailing careers@aerogen.com. Please include your name and preferred method of contact.
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