Senior Computerised System Validation/Assurance Engineer

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 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

As the Senior Computerised System Validation/Assurance Engineer, you will provide clear direction for equipment systems validation approach.
•Applying a Risk-based, best-practice approach to validation strategies.
•Assessing 21CFR Part 11 requirements.
•Assessing the validation impact of changes made to the systems/equipment.
•Ensure that Aerogen's processes, SOPs and forms for computerised systems control and validation continue to meet the requirements of relevant regulations and are fit for purpose.
•Develop & Maintain Qualification and Test Plans, aligned with the overall project plan.
•Develop documentation templates, making sure to stay compliant with standards, to ensure implementation of the validation strategy for URS, Traceability Matrix, FS, DS, Test Scripts
•Development and review of computer validation/assurance documentation (Validation Plan, IQ, OQ, PQ)
•Providing input into FAT/SAT execution and carrying out leverage evaluations.
•Contribute to the development of the project schedules and document trackers.
•Coordinate with project stakeholders making them aware of Validation requirements.
•Work closely with Vendors, Suppliers and System Integrators.
•Train, develop and manage CSV engineers to ensure objectives are communicate and delivered per the business requirements.
•Act as a Subject Matter Expert (SME) for Validation Compliance of Computerized Systems in Audits.
•SME knowledge in validation (computerised systems) and across all levels at the site, ensuring compliance with current industry regulations, guidelines and trends.

Qualifications & Experience
•A Computer Science, Engineering or Science Degree.
•Minimum 6+ years CSV as a Senior / Lead in a Pharmaceutical or relevant industry.
•Understanding of ISO 13485 and FDA/ISO, particularly 21 CFR Parts 11 & 820ion
•Experience with reviewing computer validation documentation (Validation Plans, IQ, OQ, PQ, RTM, Reporting)
•Familiarity with GAMP5 Guideline for “Risk Based approach to GxP Compliant Computerised systems
•Understanding of CSA (Computer Software Assurance) per FDA guidance desirable.

Beneficial Knowledge / Experience
•Software Development Lifecycle (SDLC)
•Implementation and Validation of ERP systems
•System Administration

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.

Senior Computerised System Validation/Assurance Engineer

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