Principal Engineer - Combination Product Operations MSAT Primary Container Engineering/SRE

Amgen•Thousand Oaks, CA

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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 to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Principal Engineer - Combination Product Operations MSAT Primary Container Engineering/SRE What you will do Let’s do this! Let’s change the world! In this vital role you will act as a cross-functional leader in Combination Product Operations (CPO) and work with internal and external teams to support the commercialization of Amgen products around the globe.

Requirements

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

Nice To Haves

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

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

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, and 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.

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