Amgen SA
Principal Engineer - Combination Product Operations MSAT Primary Container Engin
Amgen SA, Thousand Oaks, California, United States, 91362
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.
Responsibilities of this position may include:
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
What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
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 Qualifications:
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
What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
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. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Sponsorship Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
#J-18808-Ljbffr
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.
Responsibilities of this position may include:
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
What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
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 Qualifications:
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
What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
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. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Sponsorship Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
#J-18808-Ljbffr