Process Engineer III
hace 28 días
Scottsdale
Job Description The Process Engineer III is a senior-level engineering professional responsible for leading high-impact process improvement initiatives, optimizing workflows, and implementing scalable, sustainable solutions across multiple functions within the organization. This role applies advanced technical knowledge, data analytics, systems-thinking, and cross-functional collaboration to drive operational excellence and efficiency while ensuring regulatory and quality compliance. As a subject matter expert in continuous improvement methodologies, automation integration, and process engineering best practices, the Process Engineer III also provides mentorship and technical leadership to junior team members. Job Responsibilities: • Drive the identification and resolution of inefficiencies across laboratory and office workflows, ensuring all process improvements align with organizational goals and compliance standards., • Design, implement, and validate advanced process enhancements and automation strategies that prmote scalability, operational efficiency, and reproducibility., • Lead continuous improvement efforts by facilitating process mapping, root cause analyses, corrective action planning, and the development of robust control systems., • Leverage operational data, KPIs, and performance metrics to assess workflow effectiveness and identify opportunities for ongoing optimization in collaboration with cross-functional teams., • Develop and approve technical documentation, including SOPs, validation protocols, and technical reports, to support standardization and regulatory compliance., • Manage complex, cross-functional projects, ranging from automation rollouts to large-scale process validation, ensuring timely delivery of key milestones and results., • Utilize advanced analytical tools, modeling techniques, and simulation software to evaluate and enhance process performance., • Lead root cause investigations and implement corrective and preventive actions (CAPAs) to resolve process deviations and strengthen process controls., • Champion the integration of automation technologies, digital tools, and control systems that improve throughput, consistency, and data traceability., • Stay current on emerging technologies, trends, and best practices in process engineering, automation, and anatomic pathology operations to proactively drive innovation., • Oversee and contribute to validation activities for new or modified processes, systems, and equipment to ensure alignment with regulatory expectations and internal quality standards., • Serve as a strategic technical advisor and liaison across Lab Operations, Pathology, Research & Development, IT, Quality, Regulatory and administrative teams to facilitate the successful implementation of process improvements., • Engage stakeholders at all levels to ensure that process changes address operational needs while meeting quality and compliance requirements., • Represent the Process Engineering function in internal technical reviews, vendor evaluations , and cross-functional workstreams., • Deliver clear, impactful presentations and technical communications to senior leadership, project teams, and external partners to support decision-making and foster alignment., • 5–8 years of progressively responsible experience in process engineering, laboratory operations, biotechnology, or related technical disciplines., • Proven track record of leading end-to-end process improvement initiatives, integrating automation, and driving continuous improvement within highly regulated environments., • Deep understanding of Lean, Six Sigma, and other process optimization methodologies, with demonstrated success applying these tools to enhance efficiency and reduce variability., • Strong experience managing complex, cross-functional projects, including validation, system implementation and operational change management., • Proficient in data analysis and statistical tools such as Python, MATLAB, JMP, Minitab and Arena, with the ability to translate data into actionable insights., • Hands-on familiarity with automation platforms, digital workflow tools, and process control systems used in laboratory or biotech settings.., • Working knowledge of regulatory and quality standards including CLIA, CAP, FDA, ISO 13485, with a clear understanding of how to align process improvements with compliance expectations., • Strong analytical and critical thinking skills with the ability to identify inefficiencies, perform root cause analysis, and implement scalable, sustainable solutions., • Effective communicator with the ability to write clear technical documentation and deliver impactful presentations to both technical and executive audiences, • Demonstrated ability to mentor and support junior engineers or cross-functional teammates, fostering collaboration and technical growth., • Highly organized, detail-oriented, and capable of balancing multiple priorities in a fast-paced, evolving environment., • Bachelor's degree in Biomedical Engineering, Process Engineering, Industrial Engineering, or a related field required., • Master's degree in engineering, systems engineering, biotechnology, or a related discipline is preferred., • Lean Six Sigma Green Belt certification is preferred., • Combination of seated and standing work to complete the core functions of the role., • Adherence to company safety policy., • Ability to work onsite at the Company's Scottsdale, AZ headquarters approximately five (5) days a week.