Manufacturing Compliance Engineer/Senior Engineer

Join our Oceanside team and take on a meaningful role at the heart of biochemical manufacturing. You’ll collaborate across teams to resolve challenges, maintain quality system records, and ensure compliance with regulatory standards using cGMP and SOPs. Responsibilities Own and investigate deviations. Support tech transfer and commercial manufacturing. Review and approve technical documentation. Support continuous improvements. Partner with MSAT, Site Operations, and Quality Assurance to tackle quality issues and improve compliance standing. Lead operational excellence initiatives to improve processes, solve complex problems, and uphold safety, quality, and compliance standards. Manage and resolve technical and compliance issues with Quality, Technology, Maintenance, Facilities, Calibration & EH&S. Apply advanced theory, technical principles, and expert judgment to solve a wide range of difficult issues impacting multiple functions in accordance with cGMP regulations and Genentech standards. Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross‑functional partnership. Lead and/or facilitate Root Cause Analysis sessions and serve as coach and process owner for DMS Event Observer/DO Community within the function on best practices. Act as SME to regulatory agencies. Implement and follow through on corrective and preventative actions (CAPA) in accordance with timelines. Qualifications BS/BA in Life Sciences or Engineering (preferred) and 0–2 years of experience in the pharmaceutical or biopharmaceutical industry (Engineer) or 3–7 years of experience (Senior Engineer). Ability to make sound decisions about scheduling, allocation of resources, and managing priorities. Strong oral and written communication skills, and ability to decide with minimal supervision. Thorough knowledge and understanding of cGMPs and familiarity with FDA, ICH, and European guidelines. Manage assignments that are complex in nature where independent action and a high degree of initiative are required to resolve problems and develop recommendations. Experience in technical writing, such as creation and revision of Standard Operating Procedures or other technical reports/evaluations, is desirable. Work Environment / Physical Demands Environment requires gowning in hospital scrubs, bunny suits, gloves, and steel‑toe boots. Work in a clean‑room environment with large mechanical equipment, piping, and pumps connected to tanks serviced by high‑pressure steam, water, and air, creating a load environment. May work with hazardous materials. Salary & Benefits Expected salary range based on the primary location of Oceanside, CA: $80,500 (min) – $115,000 (mid) – $149,500 (max) annual. 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. EEO Statement 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 is consistent with all federal, state, or local laws. #J-18808-Ljbffr SwiftCruit