Amgen · 22 hours ago
Senior Engineer
Thousand Oaks, CA
Full-time
Hybrid
Mid, Senior Level
$120K/yr - $149K/yr
1+ years expAmgen is a biotechnology company dedicated to serving patients with serious illnesses. In this role, you will work on the development and validation of test methods for Container Closure Integrity, ensuring the safety and sterility of drug products.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Work with team of engineers in the development, validation, qualification and transfer of Title 21 of the Code of Federal Regulations (CFR) Part 11 compliant physical test methods for Container Closure Integrity (CCI) of combination products and primary containers
Ensure that primary containers carrying oncology and cardiovascular drug products maintain sterility throughout the container lifecycle, including product filling, transportation, storage, to reach the patients safely
Act as a subject matter expert (SME) regarding Container Closure Integrity Testing to support product filings, qualification of manufacturing processes, and maintenance of routine stability studies
Design, develop, and calibrate fixtures for American Society for Testing and Materials ASTM F2338 compliant vacuum decay testing of vials on Packaging Technologies and Inspection PTI-325 and PTI-440 leak detectors using SolidWorks
Develop, validate and transfer physical test methods for deliverable volume testing of primary containers carrying drug products per United States Pharmacopeia USP 697 and Good Manufacturing Practices (GMP)
Work with industry experts to advance innovative system integrity methods such as Helium Leak Detector, Wilcomat Leak Detector, high voltage leak detection, and other new emerging technologies
Serve as a domain expert for Strength of Materials, Material Selection, fluid mechanics/mass spectrometry, and transport phenomena
Principal author for test method documentation including technical method instructions, operational protocols, equipment qualification, standard operating procedures (SOPs), and technical drawings related to equipment function
Qualification
Required
Master's degree or foreign equivalent in Mechanical Engineering, Biomedical Engineering or related field
Completion of a university-level course, research project, internship, thesis, or one year of experience in the following: Maintain processes for the development, qualification validation and transfer of container closure integrity test methods for product verification, of new products and transfer of knowledge and techniques to partners
Knowledge of 21 Code of Federal Regulations CFR Part 11, Good Manufacturing Practices, United States Pharmacopeia USP 697 and United States Pharmacopeia USP 1207
Develop operational procedures and maintenance protocols for various Container Closure Integrity test equipment including vacuum decay, helium leak detection, tracer liquid and high voltage leak detection technologies
Equipment validation including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Proficiency in SolidWorks and MS Office Suite
Domain knowledge for Strength of Materials, Material Selection and fluid mechanics
Benefits
Stock
Retirement
Medical
Life and disability insurance
Eligibility for an annual bonus or for sales roles, other incentive compensation
Comprehensive employee benefits package
Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Flexible spending accounts
Discretionary annual bonus program
Sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
Morningstar.com
2026-02-04
2026-02-04
WSJ.com: US Business
2026-02-04
Company data provided by crunchbase