Principal Engineer Combination Product Operations MSAT Primary Container EngineeringSRE

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll 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

Lets do this! Lets 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

• Associates degree and 10 years of Mechanical or Chemical Engineering Physics Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry OR

• Bachelors degree and 6 years of Mechanical or Chemical Engineering Physics Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry OR

• Masters 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 well 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.

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.

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