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.

• 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.

• 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

• 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…