Sr Engineer

Career CategoryEngineeringJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Sr EngineerWhat you will doLet’s do this. Let’s change the world. In this vital role you Amgen’s Drug Product Process Engineering team in the Drug Product Technologies organization.  Reporting to the Sr Principal Scientist Visual Inspections Manager of Amgen Thousand Oaks (ATO) Drug Products Site Process Development, this role will be responsible for commercial and clinical manufacturing support in visual inspections to ensure execution excellence of new product introductions into the drug product manufacturing facility and support on-going manufacture in Thousand Oaks. The candidate will play a key role providing site leadership in visual inspections defect creations. This role will be based in Thousand Oaks, CA. Some US or international travel may be required to support Amgen’s drug product network.Leads the creation of visual inspection defect standards to enable clinical and commercial new product introductions (NPIs) and support on-going manufacture of parenteral drug products to Amgen’s drug product manufacturing facility in Thousand Oaks.Designs, implements and documents on-site DP characterization studies, working instructions, standard operating procedures, and protocols in support / ownership of visual inspection defect creations.Author and/or own high-quality technical and GMP documents.Ensuring all aspects of all visual inspection process development supports activities adheres to required policies and procedures, including safety and training.Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & global standards).Assist in the development of any existing visual inspection program to ensure continued compliance to the necessary regulations.Build and sustain excellent relationships with partners – drug product teams, NPI, QA, Process Development and manufacturing teams throughout the Amgen global network to ensure alignment between program needs and site capabilities.Build, maintain and improve visual inspection defect creations process.Provide process development expertise for visual inspections and defect creations.Demonstrate a deep understanding of Amgen’s drug product and primary container platforms, and support continuous improvement.Establishes strong working relationships with partner sites across DP Manufacturing network to foster the sharing of technical best practices, improvement opportunities and lessons learnt to deliver high-quality manufacturing processes.Acts as single Point of Contact (POC) to Amgen network as ATO defect creations leader.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Sr Engineer professional we seek is an individual with these qualifications.Basic Qualifications:Doctorate degree OR Master’s degree and 2 years of Engineering and/or Operations experience OR Bachelor's Degree and 4 years of Engineering and/or Operations experience OR Associate's degree and 8 years of Engineering and/or Operations experience OR High school diploma/GED and 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 functional area deliverables in visual inspections and defect creations from planning through completion, with measurable impact to business outcomes. Ability to set, and achieve, tactical and strategic goals in a dynamic manufacturing environment, with due considerations for competing priorities.Knowledge of aseptic processing and strong skills in applying fundamental engineering and scientific principles to the characterization of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.Experience in cGMP manufacturing environment, knowledge of cGMP’s and other global regulatory requirements.Demonstrated ability in leading multi-functional teams to advance complex projects to completion and positively influence peers and executive leadership on decision-making.Project management skills, including the ability to manage numerous projects and evaluate project resource requirements.Experience with building strong relationships in a matrix team environment, collaborating with Process Development, Project Management, Manufacturing, Regulatory, Quality and Compliance.Ability to learn and act on dynamic information at a rapid pace and escalate relevant issues to management when required.Ability to independently design and execute characterization studies, author characterization protocols, working instructions, standard operating procedures, and technical reportsProficiency in technical problem solving, critical thinking, and delivery of tech