Sr Process Development Engineer
Vor 5 Tagen
CareDx is seeking an independent and highly motivated Sr Process Development Engineer to monitor and improve a diverse collection of CLIA and manufacturing processes.
These include the processing of patient samples through various workflows in a CLIA-certified laboratory to Formulation, QC and Filling processes in Reagent Manufacturing.
The successful candidate will understand the criticality of each step of the process and closely monitor the key performance indicators that can improve the critical outgoing metrics.
They will work closely with R&D, the Clinical Lab, Quality, Supply Chain, Process Development and Manufacturing to ensure new processes are transferred smoothly.
Responsibilities: Support process optimization, technology transfer, scale-up, capacity planning, and equipment/process validation activities, as related to either Clinical Lab processes and/or Reagent Manufacturing.
Will help to develop and qualify robust, high quality, and cost-effective processes for production.
Hands-on participation for execution or training of new personnel, may be required.
Opportunities to lead projects available as needed.Responsible for process and equipment validation, including developing protocols, execution, and generating reports.Will be responsible for leading and/or contributing in cross-functional teams consisting of Manufacturing, R&D, Quality, Automation Engineering, Informatics and/or Supply Chain.
Perform project management functions to effectively drive results, manage project schedules, and communicate project status, experimental plans and results.
Position may require interaction with other global manufacturing sites, vendors or external partners.Drive implementation through operations, including setting up infrastructure, production documentation, and training on new processes and equipment.Ensure manufacturability of operations as it pertains to the utilization of staffing, facility (layout, etc.
), materials, and equipment.Work with R&D and Automation Engineers to establish equipment/instrumentation requirements and specifications.
Interfaces with vendors on procurement, installation, maintenance, etc.Active monitoring of operations through statistical based review of key metrics, including equipment status, assay performance and QC results.
Track customer complaints and respond as necessary.Responsible for ongoing technical support of sustaining operations, including troubleshooting of equipment and process problems.Generate various documentation such as process flow diagrams, operating procedures, work instructions, equipment SOP's, validation plans, reports and protocols.Conform to requirements for Design Control.
Perform design and process risk assessments, such as pFMEA.
May conduct design reviews.Apply working knowledge of Lean/Six Sigma principles in operations, utilizing various tools (VSM, 6S, Kaizen, Visual Controls, etc.)
to drive Continuous Improvement efforts.
View processes with an engineering mindset to look at process flow improvements, bottleneck analysis, batch size optimization and efficiency.
Develop metrics and controls to drive improvements in the areas of COGS, quality, yield, safety/ergonomics, and TAT.Works independently and collaboratively to make critical decisions relating to production operations, using judgment and drawing on external resources as necessary.Requirements: Bachelor's degree or higher in Bioengineering, Industrial Engineering, Mechanical Engineering, Materials Science, Chemical Engineering or related field.5+ years of process engineering, process development/manufacturing engineering experience; or Master's degree with a minimum of 4 years of experience; or equivalent combination of education and experience.Related industry experience in process improvement, scale up, transfer and validation of molecular biology-based lab processes and reagents.
Familiarity with the formulation, handling and processing of oligo and enzyme-based reagents and principles of biological processes (PCR, sequencing, etc.)
a plus.Background in automation, robotics, lab instrumentation and analytical equipment.Solid analytical skills in statistics, time-series analysis, Pareto analysis, data visualization, etc.Experience working in a CLIA, ISO13485 or cGMP regulated environment, either within the life sciences, medical devices or biopharmaceutical products highly desirable, with strong working knowledge of Design Control requirements and Quality Systems.Creative thinker, with strong problem-solving skills and ability to think outside of the box.Experience in the optimization of production processes through the use of Lean/Six Sigma tools and principles, with strong understanding of Operational Excellence concepts.Experienced with the systems used in production environments, such as the Laboratory Information Management Systems (LIMS), MES, and business systems.Experience in project management and project leadership a plus.Must have strong attention to detail and ability to handle multiple projects at once of varying scope and complexity.Excellent interpersonal skills, with demonstrated ability to communicate across disciplines, summarize and present complex topics, as well as influence others across all levels of the organization.Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide.
We believe in taking great care of our people, so they take even greater care of our patients.
#J-18808-Ljbffr
-
Process Engineer
vor 1 Woche
Brisbane, Österreich Prudentia Process Consulting VollzeitAs a Process Engineer, you will play an important role in delivering project design and support services to the diverse portfolio of projects in our Energy / Chemicals team. We are seeking outcome-focused individuals who are highly motivated, proactive, and thrive in a challenging, multi-disciplinary environment. The salary and level of responsibility for...
-
Sr. Product Engineer
vor 2 Wochen
Brisbane, Österreich Tideri Jobbörse VollzeitContribute to a High-Impact, Dynamic Environment Work on cutting-edged solutions for the future of the Energy industry About Our Client Our client is a respected player in the Energy & Natural Resources sector, boasting a global reach with over 8,000 employees.The Brisbane-based branch specialises in bitumen and other essential engineering materials,...
-
Sr. Electrical Engineer
vor 2 Wochen
Brisbane, Österreich Michael Page Australia VollzeitJoin a leading Engineering company with a global presenceLead and support a variety of mineral processing projects.About Our ClientOur client is a globally recognised leader in the Mining & Mineral Processing industry, boasting a team of over 5000 dedicated professionals. They are renowned for their commitment to innovation, sustainability, and the...
-
Sr. Product Engineer
vor 2 Wochen
Brisbane, Österreich Michael Page Australia VollzeitContribute to a High-Impact, Dynamic EnvironmentWork on cutting-edged solutions for the future of the Energy industry About Our Client Our client is a respected player in the Energy & Natural Resources sector, boasting a global reach with over 8,000 employees. The Brisbane-based branch specialises in bitumen and other essential engineering materials,...
-
Sr. Electrical Engineer
vor 4 Wochen
Brisbane, Österreich Michael Page Australia VollzeitJoin a leading Engineering company with a global presence Lead and support a variety of mineral processing projects.About Our Client Our client is a globally recognised leader in the Mining & Mineral Processing industry, boasting a team of over 5000 dedicated professionals.They are renowned for their commitment to innovation, sustainability, and the...
-
Sr. Product Engineer
vor 2 Wochen
Brisbane, Österreich Michael Page Australia VollzeitContribute to a High-Impact, Dynamic EnvironmentWork on cutting-edged solutions for the future of the Energy industry About Our Client Our client is a respected player in the Energy & Natural Resources sector, boasting a global reach with over 8,000 employees.The Brisbane-based branch specialises in bitumen and other essential engineering materials, ensuring...
-
Sr Analyst Ii Business Process Transactions
Vor 4 Tagen
Brisbane, Österreich Dxc Technology Inc. VollzeitSr Analyst II Business Process TransactionsApply locations AUS - QLD - BRISBANE time type Full time posted on Posted Yesterday job requisition id 51532907Job Description:DXC Technology (NYSE: DXC) helps global companies run their mission-critical systems and operations while modernizing IT, optimizing data architectures, and ensuring security and scalability...
-
Principal Process Engineer
vor 4 Wochen
Brisbane, Österreich Stantec Australia VollzeitPrincipal Process Engineer - Mining, Brisbane At Stantec – Energy & Resources, we are designers, engineers, and project managers.We take pride in providing innovative solutions that balance production goals with good stewardship, environmental sustainability, and regulatory requirements.Together we innovate at the intersection of community, creativity, and...
-
Process Engineer
vor 1 Monat
Brisbane, Österreich Tideri Jobbörse VollzeitThe Opportunity Veolia is seeking a Process Engineer to join our team at the Northern Water Treatment Plant in Wandoan, 4417.As a key player in our operations, you'll drive process optimisation, lead teams, and collaborate with stakeholders to deliver exceptional results.What's on offer Improve plant performance and efficiency.Develop and coach teams to...
-
Process Engineer
vor 1 Monat
Brisbane, Österreich Https:Www.Energyjobline.ComSitemap.Xml VollzeitThe OpportunityVeolia is seeking a Process Engineerto join our team at the Northern Water Treatment Plant in Wandoan, 4417. As a key player in our operations, you'll drive process optimisation, lead teams, and collaborate with stakeholders to deliver exceptional results.What's on offerImprove plant performance and efficiency.Develop and coach teams to...
-
Process Engineer
vor 4 Wochen
Brisbane, Österreich Veolia VollzeitThe OpportunityVeolia is seeking a Process Engineer to join our team at the Northern Water Treatment Plant in Wandoan, 4417.As a key player in our operations, you'll drive process optimisation, lead teams, and collaborate with stakeholders to deliver exceptional results.What's on offerImprove plant performance and efficiency.Develop and coach teams to...
-
Process Engineer
vor 4 Wochen
Brisbane, Österreich Veolia VollzeitThe Opportunity Veolia is seeking a Process Engineer to join our team at the Northern Water Treatment Plant in Wandoan, 4417.As a key player in our operations, you'll drive process optimisation, lead teams, and collaborate with stakeholders to deliver exceptional results. What's on offer Improve plant performance and efficiency. Develop and coach teams to...
-
Principal Process Engineer
Vor 5 Tagen
Brisbane, Österreich Stantec Australia Pty Ltd VollzeitPrincipal Process Engineer - Mining, BrisbaneAt Stantec – Energy & Resources, we are designers, engineers, and project managers, taking pride in providing innovative solutions that balance production goals with good stewardship, environmental sustainability, and regulatory requirements. Together we innovate at the intersection of community, creativity, and...
-
Principal Process Engineer
Vor 4 Tagen
Brisbane, Österreich Stantec Australia Pty Ltd VollzeitPrincipal Process Engineer - Mining, Brisbane At Stantec – Energy & Resources, we are designers, engineers, and project managers, taking pride in providing innovative solutions that balance production goals with good stewardship, environmental sustainability, and regulatory requirements.Together we innovate at the intersection of community, creativity, and...
-
Senior Process Engineer
vor 1 Monat
Brisbane, Österreich CAPSTONE RECRUITMENT ASIA PACIFIC VollzeitCapstone is partnering with a highly regarded multi-disciplinary Engineering Design and Project Management firm with a strong presence in the Oil & Gas, Petrochemical, Water and Wastewater, Minerals Processing, and New Energy sectors.Known for their commitment to excellence, they foster a culture that values responsibility and dedication to high-quality...
-
Senior Process Engineer
vor 4 Wochen
Brisbane, Österreich CAPSTONE RECRUITMENT ASIA PACIFIC VollzeitCapstone is partnering with a highly regarded multi-disciplinary Engineering Design and Project Management firm with a strong presence in the Oil & Gas, Petrochemical, Water and Wastewater, Minerals Processing, and New Energy sectors.Known for their commitment to excellence, they foster a culture that values responsibility and dedication to high-quality...
-
Senior Process Engineer
vor 4 Wochen
Brisbane, Österreich CAPSTONE RECRUITMENT ASIA PACIFIC VollzeitCapstone is partnering with a highly regarded multi-disciplinary Engineering Design and Project Management firm with a strong presence in the Oil & Gas, Petrochemical, Water and Wastewater, Minerals Processing, and New Energy sectors. Known for their commitment to excellence, they foster a culture that values responsibility and dedication to high-quality...
-
Senior Process Engineer
Vor 4 Tagen
Brisbane, Österreich CAPSTONE RECRUITMENT ASIA PACIFIC VollzeitAdd expected salary to your profile for insights.Capstone is partnering with a highly regarded multi-disciplinary Engineering Design and Project Management firm with a strong presence in the Oil & Gas, Petrochemical, Water and Wastewater, Minerals Processing, and New Energy sectors. Known for their commitment to excellence, they foster a culture that values...
-
Senior Software Engineer
vor 1 Monat
Brisbane, Österreich Pax8 Apac VollzeitNo matter who you are, Pax8 is a place you can call home.We are growing globally, and are now expanding across Australia, New Zealand and Asia. Culture is important to us, and at Pax8, it's business, and it IS personal.We are passionate, creative, and humorously offbeat.We work hard, keep it fun, and expect the best. We Elev8 each other.We Advoc8 for our...
-
Process Engineer
vor 2 Wochen
Brisbane, Österreich C01 Cochlear Limited (Australia) VollzeitChange people's lives and we love what you do!Cochlear develops world-leading medical devices that help people hear.As a top 50 medical device company and the market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other.Our employees tell us that the number one reason they enjoy working for...
