Job Title

Senior Specialist, Packaging & AVI Engineer page is loadedSenior Specialist, Packaging & AVI EngineerApply locations Melbourne - Australia Drug Manufacturing time type Full time posted on Posted 2 Days Ago job requisition id R17696The Role:Reporting to the Engineering Director, the AVI&P Engineer will be the subject matter expert (SME) of the Vision Inspection Equipment, Packing Equipment and Systems for Moderna Drug Product Manufacturing. The candidate will lead Inspection Vision Equipment, Packing Equipment and Systems of primary DP filled containment of sterile operations for the Melbourne site.Candidate should have knowledge of regulatory and performance requirements for process equipment used in the inspection and packaging of pharmaceutical sterile filled products and able to review and approve project documentation such as URS, functional descriptions, engineering drawings, vendor documentation as well as complete Factory Acceptance Testing (FAT) in vendor locations or in the commissioning phase of projects in the field.The AVI&P Engineer has the technical experience and will be expected to maintain timeliness, accuracy, and thoroughness throughout the project lifecycle to ensure successful execution of all technical and operational readiness activities associated with the AVI&P equipment on site.Heres What Youll Do:Your key responsibilities will be:Be the subject matter expert (SME) for all Automated Vision & Packing Systems on site including sterilization platform.Work cross-functionally supporting Operations, Quality, EHS, Digital and Validation colleagues to ensure successful detection and resolution of equipment electrical, mechanical and software related issues for routine production.Contribute to the global organization as a Subject Matter Expert in Automated Vision & Packing Systems. Develop and gain alignment on procedures and standards within internal, cross-functional teams.Independently execute, and direct others in the execution of, the design of processes and equipment by applying novel engineering concepts and techniques within the discipline. Benchmark internally and externally to investigate and recommend such designs.Support implementation of new technologies for vision equipment, including implementation of AI. Design and conduct testing to evaluate these new technologies and equipment changes as part of the technical roadmap.Participate on project teams through all phases of engineering projects related to equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.Troubleshooting equipment to determine root cause of failure modes, providing input into preventative maintenance plans, assessing change controls, CAPAs, deviations and continuous improvement initiatives.Provide technical leadership to support new product implementation and format changes. Manage required change controls to implement.Must be able to drive results on multiple complex assignments simultaneously, in addition to reviewing and guiding the work and performance of vendors and contractors.Drive development of Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment and update as required.The key Moderna Mindsets youll need to succeed in the role:We digitize everywhere possible. In this role, you''ll push the boundaries of automation and digital integration, embedding smart inspection systems and AI into our sterile manufacturing lines. Your approach will unlock higher performance, better compliance, and faster learning cycles.We obsess over learning. As technology evolves rapidly, you will constantly learn from both successes and failuresleading the adoption of novel vision and packaging innovations while staying ahead of compliance and quality demands.Heres What Youll Bring to the Table:A bachelors degree in Electrical, Mechanical, or related Engineering Area.Minimum of 6 years relevant experience supporting highly automated production equipment.Minimum 4 years of experience in a GMP environment is desirable.Experience with vision & packing systems in the pharmaceutical industry.Working knowledge of aseptic manufacturing and filling would be preferred.Experience programming and supporting a range of vision and PLC/HMI platforms.Experience working with ERP platforms such as SAP.Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence decisions. Technical writing skills required.Must be able use his/her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems.Familiarity with Excel, Word, and PowerPoint are required, and basic statistical analysis techniques are preferred.Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.Ability to represent Modernas interests, objectives, and policies in a professional and responsible manner.At Moderna, we believe that when you feel your best, you can do your best work. Thats why our global benefits and well-being resources are designed to support youat work, at home, and everywhere in between.Quality healthcare and insurance benefits.Lifestyle Spending Accounts to create your own pathway to well-being.Free premium access to fitness, nutrition, and mindfulness classes.Family planning and adoption benefits.Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.Savings and investments.Location-specific perks and extras!The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free, and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a person''s race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.Were focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com. #J-18808-Ljbffr