88-50100317 Manufacturing Engineer

Roche•South San Francisco, CA

33d•$117,624 - $168,500•Onsite

About The Position

Genentech, Inc. is seeking a Manufacturing Engineer at its South San Francisco, CA location to join the Operations, Process Support and Process Engineering team. This role involves supporting troubleshooting efforts on equipment for the release of drug substance materials, initiating and leading projects for the implementation and optimization of novel methods and techniques in drug substance production, and enhancing organizational safety through facility process/equipment improvements. The position supports the entire manufacturing process for investigational medicinal products of the drug substance, from cell bank thaw to bulk freeze, and provides support for both upstream and downstream drug substance manufacturing operations. Responsibilities include technical evaluations, troubleshooting, working with vendors on equipment or consumable design, collaborating with customer groups, network teams, and vendors, and executing daily floor operations during clinical Good Manufacturing Practice (GMP) campaigns. The role also involves giving speaker presentations across departments within the Genentech/Roche network.

Requirements

Bachelor’s degree, or foreign equivalent, in Engineering or related field
3 years of experience in job offered or related engineering or laboratory role
Quality systems
Technical writing skills for commenting on QRM exceptions and process deviations
Operating Laboratory Inventory Management systems (LIMS)
Upstream Cell Culture
Project Implementation of Novel Techniques in cross-functional team

Responsibilities

Support troubleshooting efforts on equipment in support of release of drug substance materials.
Initiate and lead projects that results in implementation and/or optimization of novel methods and techniques for drug substance production.
Enhance safety of the organization through facility process/equipment improvements.
Support the entire process for manufacturing investigational medicinal products of the drug substance from initial cell bank thaw through bulk freeze.
Support drug substance manufacturing operations upstream and downstream.
Responsible for technical evaluations and troubleshooting.
Work with vendors on equipment or consumable design.
Engage with customer groups, network teams and vendors seeking opportunities for collaboration, proactively communicating and presenting information and offering relevant data driven information to impact decisions.
Execute daily floor operations during clinical Good Manufacturing Practice (GMP) campaigns.
Give speaker presentations across departments within Genentech/Roche network.