Computer Systems Validation Engineer

Join CAI as a Computer Systems Validation (CSV) Engineer in Brisbane, Australia, where your expertise in commissioning, qualification, and validation will play a vital role in advancing the pharmaceutical, medical device, and biotechnology sectors. This position involves developing and executing validation protocols, identifying gaps, and consulting on resol…

CAI is on the lookout for talented professionals with diverse experience in the fields of commissioning, qualification, and validation to become a part of our dynamic team in Australia. A background in the pharmaceutical, medical device, or biotechnology sectors is essential. About CAI:Founded in 1996, CAI is a 100% employee-owned enterprise that has expanded year after year, reaching nearly 700 employees globally. We specialize in commissioning, qualification, validation, start-up, project management, and consulting services aimed at ensuring operational readiness for FDA-regulated and other mission-critical industries.Are You Ready?Our philosophy is straightforward: we prioritize our clients' needs, persist until we achieve the desired outcome, and are committed to doing whatever it takes to succeed.As CAI employee-owners, we pledge to uphold our Foundational Principles both professionally and personally:We act with integrityWe support one anotherWe contribute to societyWe work towards a sustainable future.At CAI, individual success translates into collective achievement; we strive to reach team objectives diligently. We emphasize Team Before Self, demonstrate Respect for Others, and foster a can-do attitude, which has been pivotal to our remarkable growth.As a CAI agent, you will have access to cutting-edge technologies in advanced medicine. You will collaborate with recognized subject matter experts, positioning YOU as a crucial contributor in the development of life-saving therapies, including COVID-19 vaccines and treatments. We are committed to investing in YOUR future through hands-on certifications and professional training. Our collaborative culture guarantees that our clients benefit from exceptional work across our comprehensive range of professional services.Key Responsibilities:Position Overview:We invite applications for the position of Senior CQV Engineer to enhance our growing operations in Australia. The CQV Engineer is tasked with creating documentation to facilitate Commissioning, Qualification, and Validation processes. Key responsibilities include writing and executing protocols, conducting field verifications, and compiling summary reports at client sites.The Senior CQV Engineer at CAI will:Develop comprehensive documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. This role also entails protocol writing and execution (including field verification), as well as the development of summary reports at client locations. Additional duties include planning and coordinating work and leading small teams in document development and execution. Qualifications:BS in Engineering or a related field (advanced degrees preferred). Proven experience in CQV processes within the pharmaceutical or biotechnology sectors. Strong communication skills and the ability to work collaboratively in a team environment.

About MegaportAt Megaport, we are redefining the tech landscape. As a pioneer in Network as a Service (NaaS), we revolutionize how businesses connect with the cloud, data centers, and each other. Our public listing on the Australian Stock Exchange and partnerships with industry giants such as Amazon, Microsoft, Google, Oracle, and IBM speak to our commitment to innovation. With our headquarters in Brisbane and a dynamic team of over 400 spread across Asia-Pacific, Europe, and the Americas, we foster a collaborative, supportive, and genuinely enjoyable workplace.Our Team CultureWe thrive on solving problems, pushing pixels, coding, and embracing the cloud. Our culture emphasizes collaboration over hierarchy, curiosity as a catalyst for growth, and valuing every voice. While we take our work seriously, we maintain a light-hearted approach. We coordinate across time zones to realize our global ambitions, trust each other to deliver results, and uphold our values without compromise. Most importantly, our customers are at the heart of everything we do.We are dedicated to enhancing diversity in the tech sector and encourage applications from individuals of all backgrounds. If you are passionate about this role, we want to hear from you, even if you don't meet every single requirement.The RoleAs Megaport expands globally, we are evolving our operations. Within our innovative Pod Model, cross-functional teams collaborate to provide seamless experiences for our customers, with the Account Manager playing a pivotal role in maintaining this alignment.This position transcends traditional account management. You will serve as the essential link between Sales, Technical, and Operations teams—taking ownership of the transition from signed agreements to successful deployments and ensuring ongoing customer satisfaction. Your responsibilities will include coordinating server deployments, addressing billing or operational issues, and proactively identifying growth opportunities within our international customer base.The ideal candidate will be highly organized, solution-oriented, and adept at navigating a fast-paced global environment. Exceptional English communication skills are essential, as is the ability to collaborate across teams and tackle complex challenges confidently.

About This Opportunity: Join Freenome as a Senior Computational Biologist specializing in Assay Development, and play a crucial role in expanding our Computational Biology, Assay Development (CBAD) team. In this pivotal position, you will leverage your scientific expertise to spearhead the development of innovative early noninvasive cancer detection tests. Your robust background in bioinformatics, statistics, and molecular biology will be integral as you formulate, document, and carry out analysis plans and reports vital for the development and characterization of Freenome’s in vitro diagnostic devices and regulatory submissions. Collaborating closely with various departments including Regulatory and Quality, Molecular Research and Development, Laboratory Operations, Biostatistics, Computational Science, and Engineering, you will facilitate the successful creation of multiple molecular assays that are central to Freenome’s diagnostic offerings. This position reports to the Director of Computational Biology and offers a Hybrid work model (2-3 days onsite in Brisbane, CA) or the potential for a fully Remote role. What You’ll Do: Design and implement development experiments for Freenome’s multiomics cancer screening tests. Collaborate cross-functionally with leaders in computational, development, regulatory, and quality teams to establish and execute a regulated development strategy aimed at securing FDA approval. Utilize your quantitative skills to devise computational methods and analyze complex experimental data to optimize and validate pioneering technologies for sample collection, preparation, and detection. Craft and execute robust experimental design and analysis plans for Development, Verification, and Validation studies while partnering closely with Biostatistics, Development, and Pre-Analytics teams. Engage with molecular and computational research teams in the advancement of Freenome’s IVD products focused on blood-based molecular assays utilizing cell-free DNA. Make a significant impact on patient lives through the development and launch of high-quality cancer screening technologies.

Join PsiQuantum as we embark on a groundbreaking journey to develop the first practical quantum computers—machines that promise to deliver extraordinary advancements in technology.Founded in 2016, our mission has been singular: to design and implement million-qubit, fault-tolerant quantum systems that will revolutionize industries such as energy, pharmaceuticals, finance, agriculture, transportation, and materials.Our innovative architecture relies on silicon photonics, combining the prowess of the advanced semiconductor manufacturing sector—partnering with leaders like GlobalFoundries—to utilize high-volume processes already producing billions of chips for telecommunications and consumer electronics. Photonics naturally scales better as photons are immune to heat and electromagnetic interference, seamlessly integrating with existing cryogenic cooling and standard fiber-optic setups.In 2024, PsiQuantum announced government-supported projects aimed at establishing our first utility-scale quantum computers in Brisbane, Australia, and Chicago, Illinois. These initiatives underscore the recognition of quantum computing's strategic and economic significance, making this the ideal time to scale our operations.Additionally, PsiQuantum is dedicated to developing the necessary algorithms and software to ensure these systems provide real-world value. Our teams collaborate directly with renowned Fortune 500 companies, including Lockheed Martin, Mercedes-Benz, Boehringer Ingelheim, and Mitsubishi Chemical, to create impactful quantum solutions.Quantum computing signifies not just an evolution of classical computing, but a revolutionary leap toward solving challenges that are currently insurmountable. The potential for transformation is immense, and we have a clear path to realize it.We invite you to join our exciting mission!

At PsiQuantum, we are on a mission to revolutionize technology through the development of the first practical quantum computers—machines that will unlock groundbreaking advancements in various fields. Our commitment, since our inception in 2016, has been to design and implement million-qubit, fault-tolerant quantum systems.Quantum computers leverage the principles of quantum mechanics to tackle challenges that are beyond the reach of even the most sophisticated supercomputers or AI systems. The potential applications are vast, impacting sectors such as energy, pharmaceuticals, finance, agriculture, transportation, materials science, and other pivotal industries.Our innovative architecture is centered on silicon photonics, allowing us to utilize advanced semiconductor manufacturing processes in collaboration with industry leaders like GlobalFoundries. This approach enables us to efficiently produce billions of chips while harnessing the inherent advantages of photonics—such as immunity to heat and electromagnetic interference, as well as seamless integration with existing cryogenic cooling and standard fiber-optic systems.In 2024, we proudly announced government-backed initiatives to establish our first utility-scale quantum computing facilities in Brisbane, Australia, and Chicago, Illinois. These projects underscore the growing acknowledgment of quantum computing's strategic and economic significance, highlighting the urgency to scale our efforts.Moreover, PsiQuantum is dedicated to developing the software and algorithms necessary to maximize the commercial potential of these systems. Our application and software teams collaborate closely with leading Fortune 500 companies—including Lockheed Martin, Mercedes-Benz, Boehringer Ingelheim, and Mitsubishi Chemical—to craft quantum solutions with real-world applicability.Quantum computing signifies a paradigm shift, offering solutions to challenges that cannot be addressed through traditional computing methods. The possibilities are immense, and we possess a clear roadmap to turn this vision into reality.Join us in shaping the future of technology.

Join our dynamic team at Via Licensing Corporation as a Salesforce Business Systems Analyst. In this pivotal role, you will oversee and enhance our Salesforce CRM system, ensuring seamless integration with our document management, patent database, and licensing systems. Collaborating closely with the Patent Licensing and Business Operations group, as well as Legal, Sales, Program Management, Accounting, IT, and Compliance teams, you will play a vital role in defining and documenting business requirements for system enhancements and new developments.The ideal candidate will have a rich background in Salesforce systems administration and a solid understanding of contract management, along with experience in QA testing processes. This is an excellent opportunity for a detail-oriented professional who thrives in a collaborative environment.

Join our dynamic maintenance team as a B2 Licensed Aircraft Engineer, where your expertise will be essential in overseeing the electrical, electronic, and avionics systems of aircraft. In this pivotal role, you will collaborate with a dedicated team of engineers and technicians, ensuring all systems are maintained to the highest safety and performance standards.Your key responsibilities will include troubleshooting issues, conducting thorough routine inspections, and executing repairs on critical aircraft avionics systems, including communication, navigation, and radar systems. This position is vital for ensuring aircraft safety and compliance with aviation regulations, making it a cornerstone role in the aviation sector.

Vera Therapeutics is a pioneering biotechnology firm dedicated to developing innovative treatments for severe immunological disorders. Our mission is to revolutionize patient care by advancing therapies that target the underlying causes of diseases. Our flagship product, atacicept, is a game-changing fusion protein that can be self-administered at home through a once-weekly subcutaneous injection. It effectively inhibits B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which are crucial in the production of autoantibodies linked to autoimmune conditions such as IgA nephropathy (IgAN) and lupus nephritis. In addition to IgAN, we are exploring other diseases where atacicept’s ability to reduce autoantibodies may significantly impact clinical outcomes. We also have an exclusive licensing agreement with Stanford University for a next-generation fusion protein, VT-109, with broad therapeutic implications across various B-cell-mediated diseases. Furthermore, we are investigating MAU868, a monoclonal antibody aimed at neutralizing BK virus infections, which can be severely detrimental to kidney transplant recipients. Vera Therapeutics holds all global developmental and commercial rights to atacicept, VT-109, and MAU868. To learn more, visit www.veratx.com.Our core values form the foundation of our culture, inspiring us daily and guiding our efforts—from recruitment to mission advancement and ultimately enhancing medical treatments for individuals suffering from immunological diseases.Position Summary:The Associate Director, GxP Systems, reporting to the Sr. Director of Commercialization Systems, will spearhead the implementation, validation, and support of GxP-regulated systems essential for Quality Assurance, Regulatory, Clinical, and Process Development & Manufacturing (PD&M) in a dynamic commercial biotech environment. This role is crucial in ensuring regulatory compliance and facilitating successful commercialization. Collaborating with Quality Assurance, Medical Affairs, Regulatory Affairs, Clinical Operations, and PD&M teams, the Associate Director will ensure that systems are validated, purpose-fit, and adaptable to evolving business needs.

About Avive:Avive Solutions, Inc. (https://avive.life) is a pioneering Automated External Defibrillator (AED) company at the forefront of a transformative journey in emergency medical response. Our innovative connected response system is rapidly capturing market attention, driven by a mission-focused team dedicated to saving lives. Sudden Cardiac Arrest (SCA) remains a leading cause of mortality in the United States, and we are committed to changing that narrative! Our organization embodies dynamism, crafting elegant and inventive solutions to tackle complex challenges. Our ultimate goal is to ensure that every cardiac arrest victim has immediate access to life-saving defibrillation.Avive is revolutionizing AED technology with a fresh approach, integrating our cutting-edge hardware with a unique software platform designed to streamline response times in SCA emergencies. We believe that this groundbreaking combination of sophisticated yet accessible technology has the potential to fundamentally enhance out-of-hospital cardiac arrest response and significantly improve survival rates.Watch this brief video to see how our team is reimagining cardiac arrest response to save lives!https://www.youtube.com/watch?v=2p4zfOWo62EExplore more about joining Avive:https://avive.life/careers/About the Role:We are looking for a Staff Firmware Engineer to play a pivotal role within Avive’s R&D team. This position serves as a player-coach, responsible for the development and leadership of new embedded firmware systems from the initial design phase through to production release, maintenance, optimization, and expansion. The successful candidate will architect, code, modify, debug, and enhance the embedded firmware of life-saving medical products.

About this Opportunity:Freenome is on the lookout for a detail-oriented and analytical Senior People Systems and Data Analyst. In this pivotal role, you will enhance our People data capabilities and facilitate insight-driven decision-making. You will lead the creation of dashboards, analytics, and reports that illuminate workforce trends and guide strategies in hiring, retention, engagement, and organizational planning. Your expertise will transform People data into practical insights through sophisticated analytics, scalable dashboards, and compelling data storytelling. While you will ensure the integrity of People systems and data, the primary emphasis will be on generating insights that empower improved business decisions.This position reports directly to the Director of People Operations and is designated as a Hybrid role.

Join our dynamic team as we expand our Airbus A220 fleet!Exciting opportunities available in Brisbane, Melbourne, and Sydney.As National Jet Systems continues to grow its fleet of Airbus A220s, we invite passionate and skilled pilots to apply for the position of First Officer. This is a unique opportunity to advance your career with a company that prioritizes best practices in crew training and promotion, ensuring a promising future for our Flight Crew.We are currently seeking applications for First Officers across our bases in Melbourne, Sydney, and Brisbane.

Role overview The Engineering Geologist / Geotechnical Engineer position at AECOM in Brisbane centers on geological assessments and geotechnical support for diverse engineering projects. This role is important for ensuring construction activities remain safe and reliable. Key responsibilities Carry out site investigations to collect geological and geotechnical information Analyze soil and rock samples to support project planning and decisions Collaborate with professionals from other disciplines to develop project solutions Prepare technical reports that document findings and offer recommendations Support strategic planning related to project execution

We are seeking a highly skilled Senior Geotechnical Engineer to join our dynamic team in Brisbane. In this pivotal role, you will be responsible for providing technical expertise in geotechnical engineering, overseeing projects from inception to completion. You'll collaborate with multidisciplinary teams and ensure compliance with industry standards while delivering innovative solutions for our clients.

Join our dynamic team as a Transport Design Engineer, where you will play a pivotal role in innovative transportation projects. In this position, you will collaborate with multidisciplinary teams to develop and implement cutting-edge design solutions that enhance mobility and accessibility.Your expertise will contribute to a variety of projects, ranging from urban infrastructure to transportation systems, ensuring that our designs meet both client specifications and regulatory standards.

Join our dynamic team at Egis Group as a Senior Geotechnical Engineer. In this pivotal role, you will lead innovative geotechnical projects and collaborate closely with multidisciplinary teams to provide expert engineering solutions. Your responsibilities will include conducting site investigations, analyzing geotechnical data, and developing design recommendations that align with industry standards.

Join AECOM as a Principal Pavements Engineer and lead innovative projects that shape the future of infrastructure. We are seeking a passionate and experienced professional to elevate our pavement engineering capabilities while delivering high-quality, sustainable designs for road, airfield, and other pavement structures.

Join our dynamic team at Colliers International as a Principal Civil Engineer, where you will play a pivotal role in leading innovative infrastructure projects. You will collaborate with multidisciplinary teams, leveraging your expertise to deliver exceptional engineering solutions that meet client needs and ensure compliance with industry standards.

About this Opportunity: At Freenome, we are looking for a dedicated Staff Machine Learning Scientist to join our expanding Machine Learning Science team within the Computational Science department. The ideal candidate will possess a robust understanding of artificial intelligence (AI), particularly in machine learning (ML) fundamentals, coupled with extensive experience in deep learning (DL) methodologies. We seek someone with a proven track record of leveraging these techniques to tackle complex research challenges, along with the ability to conduct independent research and flourish in a collaborative, cross-functional environment. In this pivotal role, you will contribute to the development of innovative algorithms aimed at early detection of cancer through blood-based tests. Utilizing your ML/DL expertise and statistical knowledge, you will create models that identify molecular signals from blood samples. Collaborating closely with computational biologists, molecular biologists, and ML engineers, you will design and execute research experiments, playing a vital role in advancing an organization committed to transforming the cancer landscape. This position reports directly to the Director of Machine Learning Science and offers a hybrid working arrangement, allowing you to work from our Brisbane, California headquarters for 2-3 days a week, or remotely.

At PsiQuantum, our mission is to pioneer the development of the first practical quantum computers—machines that can unlock the remarkable potential that this technology has long promised. Since our inception in 2016, we have dedicated ourselves to the creation and deployment of million-qubit, fault-tolerant quantum systems. Quantum computers leverage the principles of quantum mechanics to tackle challenges that are insurmountable for even the most advanced supercomputers or AI systems. Their transformative impact is anticipated across diverse sectors including energy, pharmaceuticals, finance, agriculture, transportation, materials science, and more. Our innovative architecture utilizes silicon photonics, capitalizing on the advanced semiconductor manufacturing capabilities of our partners, such as GlobalFoundries. By employing the same high-volume processes that produce billions of chips for telecommunications and consumer electronics, we harness the natural advantages of photonics: photons are unaffected by heat, immune to electromagnetic interference, and compatible with existing cryogenic cooling and standard fiber-optic infrastructure. In 2024, PsiQuantum announced government-funded initiatives to advance our first utility-scale quantum computers in Brisbane, Australia, and Chicago, Illinois. These projects signify a growing acknowledgment of the strategic and economic importance of quantum computing, emphasizing the urgency to scale our efforts. Furthermore, PsiQuantum is dedicated to developing the software and algorithms that will render these systems commercially viable. Our teams collaborate directly with leading Fortune 500 companies—including Lockheed Martin, Mercedes-Benz, Boehringer Ingelheim, and Mitsubishi Chemical—to ensure that our quantum solutions have a real-world impact. Quantum computing signifies not just an extension of classical computing, but a radical shift—a pathway to addressing challenges that cannot be resolved through any other means. The potential is immense, and we are committed to making it a reality. Join us on this transformative journey.