Main Purpose of the Position:
This position is part of Genentech’s’ Pharma Technical - individualized NeoAntigen Specific Therapy (iNeST) team based in Hillsboro, Oregon. iNeST is a next generation immunotherapy for the treatment of patients with cancer manufactured on a per patient basis. In this critical role, you will be part of a dedicated cross-functional team working on production start-up activities such as the design, installation, testing, and validation of manufacturing equipment, processes, and the quality approach for this exciting and novel technology.
Responsible for managing complete asset lifecycle, reliability, availability, and operational safety through the application of world class engineering and reliability strategy, predictive maintenance techniques, and good engineering practices. Provide project management capabilities for continuous improvement projects. Execute the site reliability and asset management strategies
Manage the asset lifecycle for all plant equipment, building systems, process equipment, and utilities.
Determine and implement Asset Criticality procedures, including impact assessments, SOPs and maintenance strategy
Support/lead startup and qualification for systems/equipment
Eliminate problems through RCA
Champion and lead continuous improvement initiatives at the site
Create, review, and approve project documents, business process documents, schedules, reports, and work instructions.
Relationship management with site Maintenance, Engineering, Technology, Manufacturing, and Quality functions
Responsible for completion of technical assessments, investigations, and data analysis.
Regularly apply theories and principles from Reliability, Project Management, and Six Sigma to independently address problems
Implement predictive maintenance strategies such as tribology, thermography, vibration, ultrasound, etc.
Ensure the integration of environment, health, safety, and security into the business processes, systems, and programs
Conduct risk assessments on production and utility equipment utilizing FMEA and other techniques.
Create and manage master data for equipment
Qualifications / Requirements:
Bachelor’s degree in Engineering and 5 - 7 years applicable experience or Master’s degree in Engineering with 3 - 5 years applicable experience.
Minimum 3 years’ experience in the pharmaceutical/biotech industry preferred, specific experience in utilities, engineering, MEP desired.
Experience from a background of manufacturing, design, or construction.
Demonstrated ability to apply experience and hands-on mechanical skills to investigate system deficiencies.
Thorough working knowledge of reliability centered maintenance practices, condition based maintenance techniques, and predictive maintenance techniques.
Understanding of biopharmaceutical manufacturing, process equipment, and supporting utility systems.
Excellent communication, facilitation, and interpersonal skills.
Utilize a wide variety of technical skills to solve multiple disciplinary complex engineering challenges.
Project management experience