Manufacturing Compliance Engineer/Senior Engineer

Responsibilities Collaborate across teams to resolve challenges, maintain quality system records, and ensure compliance with regulatory standards using cGMP and SOPs. Own and investigate deviations, support tech transfer and commercial manufacturing. Review and approve technical documentation and support continuous improvements. Partner with MSAT, Site Operations, and Quality Assurance to tackle quality issues and improve compliance. Lead operational excellence initiatives to improve processes, solve complex problems, and uphold high standards for safety, quality, and compliance. Manage and resolve technical and compliance issues with Quality, Technology, Maintenance, Facilities, Calibration & EH&S. Troubleshoot and direct resolution of quality issues through interdepartmental and cross‑functional partnership. Lead or facilitate Root Cause Analysis sessions, serve as coach and process owner for the DMS Event Observer/DO Community on best practices. Act as SME to regulatory agencies, implement and follow up on CAPA in accordance with timelines. Qualifications Engineer: BS/BA in Life Sciences/Engineering preferred, 0–2 years of experience in the pharmaceutical or biopharmaceutical industry or an education/experience combination. Senior Engineer: BS/BA in Life Sciences/Engineering preferred, 3–7 years of experience in the pharmaceutical or biopharmaceutical industry or an education/experience combination. Sound decision‑making regarding scheduling, resource allocation, and priority management. Strong oral and written communication skills. Experience with cGMPs and familiarity with FDA, ICH, and European guidelines. Experience in technical writing (creation and revision of SOPs, technical reports, or evaluations) desirable. Ability to work independently with minimal supervision; manage complex assignments requiring initiative. Work Environment / Physical Demands Gowning required (hospital scrubs, bunny suits, gloves, steel toe boots). Work takes place in a clean‑room environment with large mechanical equipment, piping, pumps, tanks, and high‑pressure steam, water, and air. Hazardous materials may be encountered. Location Oceanside, CA. Salary & Benefits Salary range: $80,500 (min) – $115,000 (mid) – $149,500 (max) annually. Pay is determined by experience, qualifications, geographic location, and other factors. A discretionary annual bonus may be available. Relocation benefits are available. Equal Employment Opportunity Statement Genentech is an equal‑opportunity employer. We employ, promote, and treat all employees and applicants on the basis of merit, qualifications, and competence. Our policy prohibits unlawful discrimination, including on the basis of protected veteran status, disability, and other statuses that are protected under federal, state, or local law. Accommodations for applicants with disabilities are available upon request. #J-18808-Ljbffr F. Hoffmann-La Roche AG