Engineer I

About the Role

Join Amgen’s mission of serving patients. Amgen is advancing a broad and deep pipeline of medicines. 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.

What You Will Do

• Support manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO).
• Partner with automation, maintenance, project management, corporate engineering, and manufacturing to develop and lead all aspects of the operation and reliability of equipment.
• Drive safety and quality compliance.
• Support the department and capital projects and provide data to support business cases and long-term strategy.
• Provide direct engineering technical support.
• Model leadership behaviors and positive values to create a positive working environment.
• Be individually accountable for consistent equipment performance and reliability.
• Be accountable for assigned results on key capital projects.
• Suggest design modifications to address risks and design in quality and safety.
• Provide oversight for verification work developed by outsourced/contract verification staff.
• Act as a liaison between Engineering, Automation, Maintenance, Instrumentation, and Quality Assurance during project planning, execution, and closeout.
• Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety practices.
• Ensure safety during commissioning, validation, maintenance, and manufacturing activities.
• Initiate and drive continuous improvement activities and projects to completion.
• Participate or lead, when required, multidisciplinary site teams (e.g., Multi-functional Team, Root Cause Analysis lead).
• Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities.
• Provide ad hoc technical support and guidance for manufacturing and maintenance.
• Mentor and provide guidance to project teams and engineers using risk-based approaches.
• Defend equipment-specific calibration, maintenance, & validation as required during regulatory inspections.
• Participate in internal audits and assess in conjunction with quality assurance.
• Assist in developing and maintaining business metric performance.

Requirements & Tech Stack

• Basic Qualifications:
• Master’s degree OR
• Bachelor’s degree and 2 years of engineering and/or manufacturing experience OR
• Associate’s degree and 6 years of engineering and/or manufacturing experience OR
• High school diploma / GED and 8 years of engineering and/or manufacturing experience.
• Preferred Qualifications:
• Bachelor's degree in engineering or another science-related field.
• 7+ years of relevant work experience with 5+ years’ experience in operations/manufacturing environment.
• Direct experience with regulated environments (FDA, OSHA, EPA, etc.).
• Knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment.
• Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution.
• Experience with combination product / medical device quality systems verification.
• Process equipment knowledge – basic principles of cell culture, fermentation, purification, filling.
• Process automation knowledge – fundamental understanding of automation infrastructure.
• Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus.
• Strong communication and technical writing skills.
• Strengths in facilitation and collaboration / networking.
• Experience in developing SOPs and delivering training.
• Individual must be a standout colleague prepared to work in and embrace a team-based environment that relies on collaboration for effective decision-making.
• Basic understanding of process improvement methodologies to mature and improve business performance (examples: PDCA, LEAN, Six Sigma, etc.).