Distribution Systems Engineer

Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 45 years.

Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.

The Opportunity

As the Distribution Systems Engineer, you will lead efforts on design, implementation, maintenance, qualification, and validation of systems that manage the storage, delivery and flow of pharmaceutical products, ensuring they reach patients and customers efficiently and reliably at our main US Distribution facility in Louisville, Kentucky. Reporting directly to the Head of Business Excellence, you are responsible for providing technical engineering support to material movement flow within the warehouse, transportation networks, and delivery systems and development of sustainable packaging solutions while adhering to strict regulatory standards and quality control measures.

What You'll Do

System Design, Implementation, Testing, and Validation:

• Design and implement systems for storing, moving, and tracking pharmaceutical products, considering factors like temperature control, storage requirements, and regulatory compliance.

• Develop and test packaging solutions to meet the needs of pharmaceutical products, ensuring durability, protection, and regulatory compliance.

• Evaluate and select suppliers of packaging materials and equipment for quality and reliability.

• Manage packaging and distribution projects from concept to implementation and ongoing monitoring.

• Support the design, development, and implementation of facilities systems to support warehouse operations.

• Conduct qualification testing and validation of building automation systems, temperature mapping, storage solutions, warehouse equipment, product transportation, and packaging solutions.

Process Optimization, Technology Integration, and Maintenance:

• Identify and implement improvements to existing distribution processes, facilities systems and packaging processes to enhance efficiency, reduce costs, meet sustainability goals and minimize errors.

• Continuously refine workflows for optimal performance.

• Develop and maintain process flow maps and site technical drawings.

• Integrate various technologies, such as warehouse automation, transport management systems, and tracking and tracing systems, into the overall distribution network.

• Ensure seamless integration of technology into distribution operations.

• Diagnose and resolve issues related to the distribution system, such as equipment malfunctions or logistical problems.

• Provide ongoing maintenance and support for distribution systems, including facilities and equipment.

Quality Assurance and Compliance:

• Ensure all distribution processes adhere to Good Distribution Practices (GDP) and other regulatory requirements, maintaining high standards of quality control and regulatory compliance.

• Ensure all packaging, distribution, and facilities activities adhere to relevant regulations and industry guidelines, such as cGMP and FDA guidelines.

• Provide technical support to quality management systems events, impact assessments, and change management processes.

• Support the upkeep of site SOPs and documentation with technical knowledge where applicable.

• Own the development and maintenance of critical site validation documentation to meet compliance standards.

Stakeholder Engagement, Data Analysis, and Documentation:

• Foster strong relationships and communicate effectively with stakeholders across various departments, including operations, logistics, and quality control, to ensure seamless distribution and facilities processes.

• Collaborate with other engineering disciplines, quality assurance, regulatory affairs, and supply chain teams to ensure good engineering practices across the site.

• Analyze data related to distribution performance to identify areas for improvement and track key performance indicators (KPIs).

• Support site problem-solving activities with technical guidance where applicable

• Generate detailed and technical reports to provide engineering insights and recommendations.

• Prepare and maintain detailed documentation for packaging, distribution, and facilities processes, including specifications, protocols, and reports.

• Ensure accurate and comprehensive documentation.

Who You Are

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Materials Science, or a related field, advanced degree (MBA, Master's or equivalent preferred

• Minimum of 5 years of experience in distribution systems engineering roles, including facilities, packaging, logistics, or similar roles.

• Extensive experience in pharmaceutical product distribution preferred.

Technical Knowledge / Skills / Competencies:

• Strong understanding of system design, technology integration, and process optimization.

• Proficiency in quality assurance, troubleshooting, and maintenance principles.

• Understanding of Business Automation Systems (BAS) and temperature control systems; specifically Desigo BAS, Yokagawa Analyzers

• Expertise in data analysis, technical writing and reporting, and regulatory compliance.

• Excellent communication and interpersonal skills to engage and collaborate with stakeholders at all levels.

• Demonstrated capabilities in supplier management, project management, and documentation.

• Knowledge of relevant regulations and industry standards, such as GMP, FDA, ISTA, ASTM, and Good Distribution Practices (GDP).

• Understanding of pharmaceutical products and their storage and transportation requirements.

• Familiarity with warehousing and logistics principles.

• Experience with various software and technologies used in distribution management, specifically SAP S/4HANA and Validation Lifecycle Management

Relocation funding is not available for this role.

The expected salary range for this position based on the primary location of Louisville, Kentucky is $90,400 - $168,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.