Hiring: Specialist, Manufacturing Production Process Owner Company: BioSpace Location: Thousand Oaks, CA Job Posted Time: 2026-09-03 10:23:45 Target Skills & Keywords : Data Lake About the job Experience: •Doctorate degree OR Masters degree and 2 years of manufacturing experience OR Bachelors degree and 4 years of manufacturing experience OR Associates degree and 8 years of manufacturing experience OR High school diploma / GED and 10 years of manufacturing experience •2 years of manufacturing experience OR Bachelors degree and 4 years of manufacturing experience OR Associates degree and 8 years of manufacturing experience OR High school diploma / GED and 10 years of manufacturing experience Required Skills: •Lets do this. Lets change the world. At Amgen, our missionto serve patientsdrives everything we do. As a Specialist Manufacturing in Drug Product (DP) Operations at our •Manufacturing site, you will play a key role in ensuring our commercial and clinical manufacturing processes are compliant, efficient, and continuously improving. This role will be supporting •Major Deviations from a DP Process Standpoint •Partner with cross-functional teamsincluding Engineering, Quality, Process Development, and Operationsto implement process improvements, support new technology introductions, and maintain robust GMP manufacturing performance. Your work will directly contribute to Amgens ability to deliver life-changing therapies to patients worldwide. •Deviation and CAPA Management •Support timely investigation and resolution of manufacturing deviations. •Participate in root cause analyses (RCA) and human performance evaluations. •Contribute to the development and implementation of effective corrective and preventive actions (CAPAs) and monitor CAPA effectiveness. Qualifications: •Advanced degree (Masters or Ph.D.) in Engineering, Biotechnology, or related field •Previous experience in Root Cause Analysis and Major Deviations •Knowledge of process validation, deviation management, and change control •Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire, JMP, Excel) •Excellent written and verbal communication skills and ability to collaborate across functions •Operational Excellence: Demonstrates attention to detail, prioritizes quality and compliance, and drives process improvements. •Technical Expertise: Applies technical knowledge to evaluate, troubleshoot, and optimize manufacturing processes. •Collaboration: Builds strong cross-functional relationships and fosters teamwork across disciplines. •Accountability: Takes ownership of deliverables and ensures timely completion of commitments. •Continuous Improvement: Identifies and implements opportunities to enhance manufacturing performance and reliability. Compensation: •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!