Sr Engineer

Sr Engineer In this vital role you will be a member of Amgen’s Drug Product Process Engineering team in the Drug Product Technologies organization. Reporting to the Sr Principal Scientist Visual Inspections Manager at 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 ongoing 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. What You Will Do Lead the creation of visual inspection defect standards to enable clinical and commercial new product introductions (NPIs) and support ongoing manufacture of parenteral drug products to Amgen’s drug product manufacturing facility in Thousand Oaks. Design, implement and document on‑site DP characterization studies, working instructions, standard operating procedures, and protocols in support of visual inspection defect creations. Author and/or own high‑quality technical and GMP documents. Ensure that all aspects of visual inspection process development activities adhere 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 with 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. 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. Establish strong working relationships with partner sites across the DP Manufacturing network to foster the sharing of technical best practices, improvement opportunities and lessons learned to deliver high‑quality manufacturing processes. Act as the single point of contact (POC) to the Amgen network as ATO defect creations leader. 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. 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 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 elevate relevant issues to management when required. Ability to independently design and execute characterization studies, author characterization protocols, working instructions, standard operating procedures, and technical reports. Proficiency in technical problem solving, critical thinking, and delivery of technical solutions with limited oversight. Demonstrated track record of taking initiative in identifying and implementing innovative approaches and ideas. Capable of organizing and communicating complex technical concepts to enable business decisions. Strong knowledge of Quality systems and Drug Product Manufacturing (GMP). Demonstrated ability to use interpersonal skills to build strong technical relationships. Self‑motivation, adaptability and a positive attitude. Excellent communication skills, both oral and written. Ability to elevate relevant issues to project lead and line‑management. Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies. What You Can Expect Of Us Compensation: The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities. A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan. Stock‑based long‑term incentives. Award‑winning time‑off plans. Flexible work models where possible. Sponsorship for this role is not guaranteed. 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