Engineer I

Amgen•Thousand Oaks, CA

1d•Onsite

About The Position

Amgen is a biotechnology company focused on serving patients living with serious illnesses by pioneering biotech in the fight against tough diseases since 1980. They focus on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease, reaching millions of patients annually. Amgen is advancing a broad pipeline of medicines for various conditions, and as part of their team, employees contribute to researching, manufacturing, and delivering innovative medicines. The company fosters a collaborative, innovative, and science-based culture. In this vital role, the Engineer I will support manufacturing processes in the Thousand Oaks Pilot Plant. This includes providing operational support, troubleshooting, and optimizing assigned equipment, as well as applying engineering principles to the design and implementation of new equipment (Stainless and Single Use Systems). The role involves supporting system reliability and operational optimization, identifying performance risks, and implementing risk reduction strategies. The Engineer I will lead and execute improvement efforts, support technical investigations, root cause analysis, and equipment troubleshooting. They will apply structured problem-solving methodologies, analyze data to develop engineering solutions, and support new product and technology introductions. Responsibilities also include collecting, organizing, analyzing, and presenting results for operational issues and engineering projects, providing onsite day-to-day technical support, and applying process engineering principles to equipment design, specification, installation, startup, and validation. The role requires assisting with project activities, translating user and process requirements into engineering documentation, and effective communication with cross-functional teams. Additionally, the Engineer I must support a safe working environment by adhering to all pertinent environmental health/safety practices, rules, and regulations.

Requirements

Master’s degree and 2 years of Engineering experience OR Bachelor’s degree and 4 years of Engineering experience OR Associate’s degree and 6 years of Engineering experience OR High school diploma / GED and 8 years of Engineering experience.
Required flexibility to support 24/7 operations, including scheduled weekend shifts, after-hours coverage, and on-call rotation.

Nice To Haves

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or Bioengineering.
Direct experience with regulated environments (e.g. FDA, cGMP, OSHA, EPA, etc.).
Subject Matter Expert and hands-on experience with complex manufacturing process equipment including sophisticated troubleshooting, reliability and performance improvements, and design optimization.
Direct experience in equipment engineering and problem solving for cleaning, centrifuges, chromatography systems, and/or filtration systems.
Foundational knowledge of Maximo or equivalent Asset Management System for managing equipment maintenance and asset lifecycle.
Solid understanding and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.
Experience in corrective and preventative actions, and commissioning practices.
Experience supporting design and startup engineering directly related to bulk biopharmaceutical production including process equipment and facilities design, procurement, construction, startup, and validation.
Demonstrates independence, strong self-motivation, and organization, with the ability to manage multiple priorities in a project-based environment.
Effective in communication, facilitation, and collaboration.
Demonstrates a strong team-oriented mindset and actively contributes to a collaborative culture that supports effective decision-making.
Applies a continuous improvement mindset in daily activities and promotes a strong commitment to safety in all aspects of work.
Ability to apply sophisticated and diverse engineering principles to the design and implementation of major system modifications, introduction of new equipment, processes, and capital projects.
Develop technical solutions to sophisticated problems requiring the regular use of resourcefulness and creativity.
Develops contingency plan for potential obstacles or setbacks.
Mentorship experience with peers or new team members on complex systems, equipment, machines, and/or processes within their area of expertise.
Demonstrates interest in continuous learning opportunities around new tools, techniques, and configurations to enhance their analytical abilities.
Strong leadership, technical writing, and communication/presentation skills.

Responsibilities

Providing operational support, troubleshooting, and optimization for assigned equipment.
Advising and applying engineering principles to the design and implementation of new equipment (Stainless and Single Use Systems).
Support system reliability and operational optimization efforts.
Identify system performance risks (e.g. single point of failure or obsolescence) and implement risk reduction strategies.
Lead and execute improvement efforts, including identifying cycle reduction time opportunities, efficiency gains, and yield improvement opportunities.
Support technical investigations, root cause analysis, and equipment troubleshooting activities.
Apply structured problem-solving methodologies with guidance.
Analyze data and assist in developing engineering solutions using data techniques and methodologies (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.).
Support new product and technology introductions by assisting with engineering assessments, equipment modifications, and execution of engineering runs.
Collect, organize, analyze, and present results for operational issues and engineering projects of small scope and complexity.
Provide onsite day-to-day technical support for equipment and process troubleshooting.
Apply process engineering principles to support the design, specification, installation, startup, and validation of process equipment and systems.
Assists with project activities by performing engineering studies and assessments for process equipment systems.
Translate user and process requirements into engineering documentation and support design development in alignment with standard engineering practices.
Communicate effectively with supervisors, cross-functional teams, and support staff to escalate issues and contribute to solutions.
Support a safe working environment by aligning with all pertinent environmental health/safety practice, rules and regulations.

Benefits

Competitive benefits
Collaborative culture
Professional and personal growth and well-being
Comprehensive employee benefits package
Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
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