Amgen · 1 day ago
Principal Engineer - Combination Product Operations MSAT Primary Container Engineering/SRE
Thousand Oaks, CA
Full-time
Onsite
Senior Level, Lead/Staff
4+ years expAmgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. The Principal Engineer will act as a cross-functional leader in Combination Product Operations, supporting the commercialization of Amgen products globally.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Lead technical coordination with key primary component suppliers
Lead primary component improvement projects related to customer complaints, aseptic filling, lyophilization and inspection operations for the manufacture of commercial biopharmaceuticals
Development and management of Integrated Project Plans and program dashboards/communications
Determine User Requirement Specifications of primary container closure systems for new and existing Amgen products
Support integration of primary containers into new and existing devices/combination products
Support on-going Deviation/CAPA and Change Control processes
Support development of characterization methods for mechanical and physical properties of primary components
Collaborate extensively with internal and external project teams, i.e. manufacturing, vendors, quality, regulatory, etc
Develop and share best practices and tools
Qualification
Required
High school diploma / GED and 12 years of Mechanical or Chemical Engineering, Physics, Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry OR
Associate's degree and 10 years of Mechanical or Chemical Engineering, Physics, Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry OR
Bachelor's degree and 6 years of Mechanical or Chemical Engineering, Physics, Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry OR
Master's degree and 4 years of Mechanical or Chemical Engineering, Physics, Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry OR
Doctorate degree and 2 years of Mechanical or Chemical Engineering, Physics, Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry
Preferred
Excellent written and verbal communication skills together with demonstrated ability to work in a team environment
Proven track record of leading and executing cross-functional projects
Direct experience with the manufacturing process and material science of primary packaging components (glass/elastomers/polymers) for medical (aseptic) applications
An Operational Excellence approach to work, driving rapid results
A passion to deliver excellent work results
Broad understanding of Combination Product Design Controls and regulatory requirements on a global scale
Program and project management skills including: Strategic planning, execution and prioritization - integrating people/processes to achieve high performance, with detailed tracking of progress
Proactive risk assessment, management and mitigation
Change management; ability to lead and thrive in ambiguous environment
Consistent track record of success in operationalizing and executing critical initiatives
Emotional Intelligence skills including: Executive presence across functions and different levels of leadership, Influencing, understanding & addressing team dynamics, Navigating within a matrix environment
Benefits
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
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
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
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