This position is part of Genentech’s exciting iNeST program. iNeST (individualized Neoantigen Specific Therapy) program is an RNA-based cancer therapy targeting neoantigens manufactured on a per-patient basis.
In this role, you will create and execute the maintenance strategy for production equipment intended to produce medicine on a per-patient basis. You will serve as the technical expert for production equipment, drive problem elimination, provide analysis/optimization of system performance, and participate in asset lifecycle activities. You will perform calibrations, manage standards, manage spare parts, and update master data/procedures. This position will also perform various maintenance and repair activities and manage small projects to meet the requirements of a new production facility.
Support the installation, maintenance, operation and repair of all systems, subsystems, and equipment within the iNEST facility.
Serve as the maintenance lead for all production equipment
Complete all maintenance and calibration procedures for facility, utilities, and equipment.
Update SOPs, request master data as required.
Comply with Good Documentation Practices, current Good Manufacturing Practices, and other compliance related items.
Skills desired include robotic system maintenance, small scale filling, lab equipment maintenance
Experience in personalized health care environment desired
Interface, collaborate and support various groups and organizations within Roche/Genentech as well as external OEMs, vendors, service providers and business partners to:
Develop and implement safe work practices
Optimize equipment maintenance and repair strategies
Maximize equipment uptime
Develop equipment life cycle strategies
Develop various training and qualification materials for new equipment
Support conceptual and detailed design, planning, implementation, commissioning and validation of new and existing process equipment
Provide Factory Acceptance Testing (FAT) support on new process equipment and systems if necessary
Event Lead during major unplanned equipment downtime events
Effectively work to manage change, discrepancies and other issues as they arise
Thorough working knowledge of Predictive Maintenance philosophy and techniques, pumps, valves, mechanical seals, motors and proper lubrication, shop tool operation and safety, cGMP compliance, data historian
Thorough working knowledge of pharmaceutical drug substance, filling, freeze drying, and packaging equipment operation, maintenance and repair.
Must continuously demonstrate the ability to work safely in an environment containing hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, varying electrical voltages and moving machinery.
Ability to read and Understand P&lDs, work from Standard Operating Procedures (SOPs) and common office applications
Knowledge of and ability to use Computerized Maintenance Management Systems.
Demonstrate effective communication skills including preparing technical reports, the revision of various technical documents and procedures.
Qualifications / Requirements:
High School diploma or equivalent. College degree, technical degree, certificate, or coursework a plus.
7 years minimum experience in a pharmaceutical/biotech, industrial / manufacturing maintenance/operation environment.
Experience with cell therapy manufacturing is preferred
Demonstrated ability to apply experience and hands-on mechanical skills to investigate system deficiencies.
Key to this position is the demonstrated ability to provide technical leadership and teamwork in a cGMP environment across functional and organizational boundaries
Understanding of biopharmaceutical manufacturing, process equipment, and supporting utility systems.
Excellent communication, facilitation, and interpersonal skills.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.