Sr Engineer

Job Title Senior Engineer – Drug Product Process Engineering (Visual Inspections) Location Thousand Oaks, CA (with occasional US or international travel) Responsibilities Provide commercial and clinical manufacturing support in visual inspections to ensure execution excellence of new product introductions (NPIs) into the drug product manufacturing facility and support ongoing manufacture. Lead the creation of visual inspection defect standards and develop the visual inspection defect creation process. Design, implement, and document on‑site DP characterization studies, working instructions, SOPs, and protocols related to visual inspections. Author and maintain high‑quality technical and GMP documents. Ensure all visual inspection process development activities adhere to policies, procedures, safety, training, and applicable regulations (FDA, EU, global standards). Assist in the ongoing development of the visual inspection program to maintain regulatory compliance. Build and sustain relationships with partners—drug product teams, NPI, QA, Process Development, and manufacturing—to align program needs with site capabilities. Provide process development expertise for visual inspections and defect creations. Foster continuous improvement and share best practices with partner sites across the DP manufacturing network. Act as the single point of contact for defect creations across the Amgen network. Basic Qualifications Doctorate degree or Master’s degree and at least 2 years of Engineering and/or Operations experience. Bachelor’s degree and at least 4 years of Engineering and/or Operations experience. Associate’s degree and at least 8 years of Engineering and/or Operations experience. High school diploma/GED and at least 10 years of Engineering and/or Operations experience. Preferred Qualifications Advanced degree in engineering, biotechnology, life sciences, or related discipline with 4+ years of drug product process development experience in the pharmaceuticals/biotechnology industry. Demonstrated expertise in leading visual inspection and defect creation deliverables from planning through completion, with measurable impact. Knowledge of aseptic processing and strong skills in applying fundamental engineering and scientific principles to freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection. Experience in a cGMP manufacturing environment and knowledge of cGMP and global regulatory requirements. Strong project management skills, ability to manage multiple projects, and evaluate resource requirements. Ability to build relationships in a matrix team environment with Process Development, Project Management, Manufacturing, Regulatory, Quality, and Compliance. Excellent communication skills, critical thinking, and ability to deliver technical solutions with limited oversight. Proactive in identifying and implementing innovative approaches and ideas. Benefits Salary range for this role in the U.S. (excluding Puerto Rico) is 115,494.60 USD – 156,257.40 USD per year, with potential for additional compensation through a total rewards plan that may include health and welfare plans, a retirement and savings plan, a discretionary annual bonus, stock‑based long‑term incentives, time‑off plans, and flexible work models where applicable. Equal Opportunity Employer Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr Amgen Inc. (IR)