Specialist Manufacturing - Production Process Owner

• Support change control activities to ensure GMP, regulatory, and operational compliance
• Evaluate and justify process or equipment changes and assist with project execution
• Participate in continuous improvement and operational excellence initiatives to enhance safety, quality, and efficiency within DP operations
• Support implementation of new processes, equipment, and major initiatives within Drug Product operations
• Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
• Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
• Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
• Develop and implement data-driven solutions to improve yield, reliability, and compliance
• Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements
• 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
• Assist in developing and executing process validation protocols and reports
• Collect, analyze, and interpret validation and process monitoring data to ensure process robustness and compliance
• Support establishment of process parameters, control limits, and performance reporting
• Initiate, revise, and approve controlled manufacturing documents within Amgen's electronic document management system (CDOCs)
• Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards
• Maintain documentation to accurately reflect operational practices and regulatory requirements

Doctorate degree OR Master's degree and 2 years of Manufacturing support experience OR Bachelor's degree and 4 years of Manufacturing support experience OR Associate's degree and 8 years of Manufacturing support experience OR High school diploma / GED and 10 years of Manufacturing support experience

• Advanced degree (Master's or Ph.D.) in Engineering, Biotechnology, or related field
• Experience in aseptic Drug Product or biologics manufacturing
• Experience in Automated/Manual Visual Inspection (AVI/MVI) Operations
• 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

• 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