Thermal Engineering - Lab Engineer
Amgen
Summary
This Engineer position is part of the Thermal Engineering group within Combination Product Operations. The successful candidate will support laboratory operations by performing and maintaining compliant testing activities in alignment with GMP, safety, and regulatory requirements.
Job description
What you will do
This Engineer position is part of the Thermal Engineering group within Combination Product Operations. The successful candidate will support laboratory operations by performing and maintaining compliant testing activities in alignment with GMP, safety, and regulatory requirements.
Responsibilities
- Execute laboratory testing in accordance with approved test protocols, operating standards, SOPs, regulatory requirements, and applicable safety procedures.
- Operate and support laboratory testing equipment, including compression testers, vibration systems, environmental chambers, vacuum systems, and drop testers.
- Plan, schedule, and coordinate laboratory maintenance activities, including equipment calibration, troubleshooting, preventive maintenance, and vendor visits.
- Troubleshoot and perform routine maintenance on laboratory equipment to ensure uninterrupted test execution.
- Collaborate with cross-functional partners (R&D, QA/QC, Supply Chain, Maintenance, Manufacturing, and Regulatory) on protocol review, test preparation, change control, deviations, CAPAs, and controlled documentation.
- Support engineers with internal experiments and studies by providing guidance on appropriate test methods and execution.
- Apply engineering and project management principles to support qualification of thermal shipping systems and temperature monitoring devices in compliance with GMP requirements.
- Coordinate and communicate effectively with internal stakeholders and external vendors to organize maintenance and service activities.
- Adhere to and demonstrate working knowledge of Amgen EHS&S policies and procedures.
- Work effectively within Amgen's external vendor and contractor management processes.
- Safely operate forklift equipment as required.
- Perform physical tasks including lifting objects up to 60 pounds.
- Lead or support equipment procurement projects and provide regular status updates on vendor performance and project progress.
- Drive laboratory improvement initiatives to enhance efficiency, reliability, and compliance.
- Maintain clear, timely communication with the team regarding laboratory equipment status, availability, and issues.
Basic Qualifications
- Master's degree OR Bachelor's degree and 2 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
Preferred Qualifications
- Laboratory operations experience preferred, particularly within biotechnology, biomedical, chemical, or mechanical disciplines.
- Relevant experience in the pharmaceutical or biotechnology industry, with demonstrated success in equipment maintenance, troubleshooting, vendor management, and test execution.
- Strong organizational, project management, and written and verbal communication skills.
- Demonstrated capability in technical presentations, issue analysis, and problem-solving.
- Proven ability to collaborate and communicate effectively with technically and culturally diverse teams, influence stakeholders toward common goals, and deliver high-quality results under aggressive timelines.
- Ability to manage multiple tasks and priorities concurrently in a fast-paced environment.
- Experience with Maximo Work Order process and EHS&S requirements.
- Proficiency with relevant systems and software, including SAP, Maximo, Microsoft Office (Visio, Excel, Word, PowerPoint), CDOCS, Efinity (Ariba), Smartsheet, and related tools.
Requirements
- Master's degree OR Bachelor's degree and 2 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
- Execute laboratory testing in accordance with approved test protocols, SOPs, regulatory requirements, and safety procedures
- Operate and support laboratory testing equipment including compression testers, vibration systems, environmental chambers, vacuum systems, and drop testers
- Coordinate laboratory maintenance activities including equipment calibration, troubleshooting, preventive maintenance, and vendor visits
- Troubleshoot and perform routine maintenance on laboratory equipment
- Collaborate with cross-functional partners on protocol review, test preparation, change control, deviations, CAPAs, and controlled documentation
- Apply engineering and project management principles to support qualification of thermal shipping systems and temperature monitoring devices in compliance with GMP
- Safely operate forklift equipment as required
- Perform physical tasks including lifting objects up to 60 pounds
Benefits
- Health Insurance
- Dental Coverage
- Vision Coverage
- Life Insurance
- Disability Insurance
- Retirement and Savings Plan
- Flexible Spending Accounts
- Discretionary Annual Bonus
- Stock-Based Long-Term Incentives
- Paid Time Off
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.