Career Category

Job Description

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.

Senior Engineer

What you will do

Let’s do this. Let’s change the world. In this role the Senior Engineer will support the development and implementation of all Commissioning, Qualification and Validation (CQV) of all GMP equipment and processes at the Amgen AOH facility. The position is a key role in the Process Development group and the candidate must manage and/or apply extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance, validation and alteration of systems, facilities and/or processes. This position will also be required to apply advance and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process characterization, optimization, scale up or manufacturing support projects.

The Senior Engineer will complete this via planning, implementing and monitoring the risk-based validation strategy, which can be followed via the created documented evidence trail. Within the Amgen AOH facility this entails introduction of new products, new secondary packaging technology and cold chain activities.

The Senior Engineer position reports into the Senior Manager Engineering under Process Development at the Amgen Ohio facility. This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations in the Amgen Ohio manufacturing facility.

The position is expected to travel for approximately 25%.

Outputs

CQV (Commissioning, Qualification and Validation)

• Lead and support the execution of Characterization strategy tasks.
• Perform periodic validation reviews.
• Develop and execute protocols.
• Complete the CQV deliverables of projects within schedule, budget and quality constraints.
• Work with other disciplines for large and/or highly complex process, system and facility modifications.

Relationships

The Senior Engineer is expected to build a network of FDP CQV expertise across the Amgen commercial operations for product assembly, label and packaging.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree & 2 years of relevant job experience in a GMP environment

Or

Bachelors degree & 4 years of relevant job experience in a GMP environment

Or

Associate degree & 8 years of relevant job experience in a GMP environment

Or

High school diploma / GED and 10 years of relevant job experience n a GMP environment

Preferred Qualifications:

• Excellent written and verbal skills together with the ability to work in a team environment.
• Consistent track record of leading and executing multi-functional projects.
• Strong team work, excellent interpersonal and communication skills.
• Direct experience with medical devices/combination products and associated manufacturing process.
• Experience of working with equipment suppliers.
• Knowledge of regulations Eudralex Annex 15, FDA CFR 11, 210 and 211.
• Knowledge of guidelines GAMP5, ASTM E2500, ICH.
• Ability to work in a highly regulated and ever changing industry.
• Ability to learn and rapidly adapt to new requirements in a fast paced environment.
• An Operational Excellence approach to work product – driving rapid results.
• A passion to deliver an excellent work product and develop others with an infective positive attitude!

What you can expect from 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, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.

Salary Range