Engineer I - Process Development

Amgen; New Albany (OH); Hybrid; USD 88,000 - 119,000; Full time

Benefits offered by this job

Retirement plan

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

Flexible spending accounts

Annual bonus

Stock-based incentives

Paid time off

Remote work options

Hybrid work model

Job summary

Amgen’s Process Development group at the New Albany site (AOH) seeks an Engineer I to support the development and implementation of technical solutions for FDP GMP operations. You will engage in process characterization, scale-up, validation, and manufacturing support across multiple engineering areas.

The role emphasizes collaboration across functions, applying diverse engineering principles, and delivering improvements in productivity and capacity while ensuring compliance with regulatory

Qualifications

• Requires GMP regulated environment experience or education.
• Demonstrated ability to work in cross-functional teams.
• Strong communication and problem-solving skills.

Responsibilities

• Support development and implementation of technical solutions for FDP GMP operations at AOH.
• Coordinate multiple complex projects involving design, validation and optimization of processes and equipment.
• Provide technical operations support for continuous improvement of packaging lines capacity and performance.

Skills

GMP experience

Teamwork

Interpersonal skills

Equipment knowledge

Regulatory awareness

Education

Master’s degree

Bachelor’s degree + 2 years GMP

Associate’s degree + 6 years GMP

High school diploma / GED + 8 years GMP

Job description

Career Category Process Development 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.

Engineer I - Process Development

What you will do

Let’s do this. Let’s change the world. In this role the Engineer will support the development and implementation of technical solutions for a variety of engineering initiatives supporting the FDP commercial GMP operations at AOH. 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, validation, maintenance 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.

Outputs Project Management

Key responsibilities will include supporting the Technical Transfer of the Amgen product portfolio to AOH. Additional responsibilities will include the provision of technical operations support for the continuous improvement of packaging lines capacity and performance, and advisory of technical improvement projects. The Engineer must ensure effective communication throughout the Amgen commercial site network with all partners and deliver on technical improvements.

Technical Support

Act as a subject matter expert for FDP GMP operations at AOH, and primarily as technical support for new process equipment and technology. This will include GMP process equipment design, testing, characterization and validation. The Engineer will author such documents as well as be responsible for the execution of said protocols. The Engineer is expected to use technical process knowledge and identify the required expertise to resolve process challenges as needed.

Operational Excellence

Responsible for supporting the delivery of productivity, throughput and general capacity improvements across the AOH manufacturing lines by analyzing, designing, and implementing manufacturing and business process improvements.

Relationships

The Engineer is expected to build a network of FDP expertise within AOH and across other Amgen commercial operations for product assembly, label and packaging. The position is expected to bring to bear this network in support of technical expertise for equipment design, testing, characterization and validation at AOH.

What we expect of you

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

Basic Qualifications

• Master’s degree OR Bachelor’s degree and 2 years of working in a GMP regulated environment
• Or Associate’s degree and 6 years of working in a GMP regulated environment
• Or High school diploma / GED and 8 years of working in a GMP regulated environment experience

Preferred Qualifications

• Track record of contributing to multi-functional projects.
• Strong team work, excellent interpersonal and communication skills.
• Experience with devices/combination products and the associated manufacturing process.
• Experience of working with equipment suppliers.
• Ability to work in a highly regulated and ever changing industry.
• Ability to learn and rapidly adapt to new requirements in a fast moving 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 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.

• 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

Salary Range

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.

Salary Details

Salary Range 88,281.00USD -119,439.00 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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.

Amgen anticipates accepting applications until 5/21/25; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

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.