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Senior Quality Engineer - Digital Transformation
About Aerogen:
Headquartered in the vibrant city of Galway, 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 16 million patients in over 75 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 Senior Quality Engineer – Digital Transformation at Aerogen will play a crucial role in our ongoing digital transformation initiatives. Collaborating with cross-functional teams, both internal and external, this successful candidate will focus on digitizing our manufacturing and quality systems processes, including system sourcing, installation, validation, and production.
What are the key responsibilities?
• In collaboration with the Digital Transformation team and key stakeholders in the business ensure that the creation, validation, sustaining and update of the digital transformation strategy conforms to current best practice and adheres to all relevant /applicable quality and regulatory standards.
• Represent Quality and Regulatory in all scoping, configuration, and sourcing activities required to ensure the success of digital transformation.
• Collaborate with the digitization transformation team to ensure that a value stream mapping of the processes has been prepared and all inputs captured within the user requirements specification.
• Ensure that all inputs to the system; Man, Methods, Materials, Measurements equipment have been optimized and work seamlessly to produce the desired output – a conforming product or process.
• Ensure that data migration and the integrity of that data is planned, risk assessed with mitigations and executed to plan.
What education and experience are required?
• Level 8 Degree in a STEM discipline required with a strong computer software element desirable.
• 8 years’ experience in a manufacturing environment with at least 2 years in a Quality Function in a Medical Device or Pharmaceutical environment.
What key skills will make you great at the role?
• Quality experience in the identification, installation and operation of GxP -relevant IT Systems such as ERP, MES, IMS, eQMS etc.
• The successful candidate is required to demonstrate excellent business acumen, a thorough understanding of business requirements, identification of risks, mitigating those risks, resolving problems and working with the business partners to ensure success with the digitization strategy.
• Excellent verbal and written communication skills
• Strong capabilities in planning and coordination.
• Comprehensive knowledge and understanding of the quality and regulatory requirements specific for Aerogen.
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:
• 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
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.
Headquartered in the vibrant city of Galway, 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 16 million patients in over 75 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 Senior Quality Engineer – Digital Transformation at Aerogen will play a crucial role in our ongoing digital transformation initiatives. Collaborating with cross-functional teams, both internal and external, this successful candidate will focus on digitizing our manufacturing and quality systems processes, including system sourcing, installation, validation, and production.
What are the key responsibilities?
• In collaboration with the Digital Transformation team and key stakeholders in the business ensure that the creation, validation, sustaining and update of the digital transformation strategy conforms to current best practice and adheres to all relevant /applicable quality and regulatory standards.
• Represent Quality and Regulatory in all scoping, configuration, and sourcing activities required to ensure the success of digital transformation.
• Collaborate with the digitization transformation team to ensure that a value stream mapping of the processes has been prepared and all inputs captured within the user requirements specification.
• Ensure that all inputs to the system; Man, Methods, Materials, Measurements equipment have been optimized and work seamlessly to produce the desired output – a conforming product or process.
• Ensure that data migration and the integrity of that data is planned, risk assessed with mitigations and executed to plan.
What education and experience are required?
• Level 8 Degree in a STEM discipline required with a strong computer software element desirable.
• 8 years’ experience in a manufacturing environment with at least 2 years in a Quality Function in a Medical Device or Pharmaceutical environment.
What key skills will make you great at the role?
• Quality experience in the identification, installation and operation of GxP -relevant IT Systems such as ERP, MES, IMS, eQMS etc.
• The successful candidate is required to demonstrate excellent business acumen, a thorough understanding of business requirements, identification of risks, mitigating those risks, resolving problems and working with the business partners to ensure success with the digitization strategy.
• Excellent verbal and written communication skills
• Strong capabilities in planning and coordination.
• Comprehensive knowledge and understanding of the quality and regulatory requirements specific for Aerogen.
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:
• 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
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.
Location
Ireland - Head Office (B2)
Ireland - Head Office (B2)
Department
QA/RA
QA/RA
Job Title
Senior Quality Engineer - Digital Transformation
Senior Quality Engineer - Digital Transformation
Salary
Experience
City
Galway
Galway
Country
Ireland
Ireland
