This internship position is within the Facilities & Engineering organization at Genentech’s Vacaville facility. Vacaville Operations is a large‑scale mammalian cell culture production facility designed around the monoclonal antibody (MAb) platform. It is one of six Drug Substance production sites in the Roche/Genentech Biologics production network. The site consists of two large-scale manufacturing facilities (CCP1 and CCP2), a hub warehouse, and QC laboratories that serve both local and network production operations. Further insight into the Vacaville manufacturing process can be found at http://www.gene.com/topics/manufacturing. In this position, you will support the Facilities & Engineering organization that is responsible for life-cycle management and maintenance of all site equipment and facilities, utility systems operations and site services at the Vacaville Drug Substance Manufacturing Facility to maintain GMP/regulatory compliance. You will provide engineering, scientific and technical judgment as part of a team responsible for delivering high-quality biopharmaceutical products to patients. Integrity, accountability, and strong dedication to the patients we serve are critical to this role. Possible assignments include, but are not limited to the following: · Learn the specific activities related to technical support, routine maintenance, and problem-solving including equipment troubleshooting and utilizing equipment trends to ensure reliable system performance in a cGMP environment. · Assist the Genentech Vacaville Engineering team in completing core functional responsibilities. Generally, Engineering supports the Design and Implementation of Capital Projects by generating design options and recommendations and by providing oversight of the technical change control process during implementation. Our intern may also provide field surveying of process & utility systems, data collection & handling as well as document verification & updates. · Learn and apply cGMP principles. · Assisting in determining ways to reduce human error in F&E in order to help us with our site goal of increasing golden batches. · Determine the consequences of failures in facilities and engineering and how this can impact our products, patients, and reputation. Research best practices to reduce microbial contamination in the pharmaceutical manufacturing environment. · Perform engineering calculations for process equipment, as needed. · Review vendor drawings, walk-down of piping and instrumentation diagrams, participate in equipment design, instrument specification, and unit operations data review. · Gain an understanding of how technical change control and continuous improvements are implemented for cGMP manufacturing equipment and systems. Benefits For Internship · Develop general knowledge/skills/experience to maintain & support a GMP manufacturing facility. · Develop familiarity with facilities & engineering activities and workflows. · Develop a high sense for quality and project management tasks. · Exposure to Genentech business processes, people and culture. · Develop service-oriented communication and team orientation skills. · Gain an understanding of how technical change control and continuous improvements are implemented for cGMP manufacturing equipment and systems. · Network with Genentech professionals while summarizing project highlights and accomplishments for poster/oral presentation at staff/department meetings. Qualifications · Recently graduated or enrolled in either an undergraduate (junior year or higher) or graduate program in the field of engineering or equivalent. · If enrolled in an academic program, must be able to work at least part-time during the academic year. Exact hours can be flexible. · GPA 3.0 and above. · Demonstrated proficiency in the application of basic engineering and/or scientific theories, principles and techniques. · Possess strong analytical skills plus technical and mechanical aptitude. · Candidate must be highly motivated, be able to work independently, as well as in a team, and have good organizational, verbal and written communication, and time management skills. · Ideal candidate would be someone with solid mechanical aptitude, a passion for learning how things work, and is solution-oriented. https://careers.gene.com/us/en/job/GENEUS202202108042EXTERNALENUS/Intern-Pharma-Technical-Operations-Facilities-and-Engineering/?utm_source=linkedin&utm_campaign=job-share&utm_medium=social-share Josefine Fleetwood, (she/her) Employer Relations Manager Oregon State University | College of Engineering 116 Johnson Hall - Room 112 541-737-7286 Josefine.fleetwood@oregonstate.edu<mailto:Josefine.fleetwood@oregonstate.edu> [cid:image001.jpg@01D8394D.ACD2C9B0]
