Engineer I - Process Development

BioSpace; New Albany (OH); Hybrid; USD 75,000 - 110,000; Full time

Benefits offered by this job

Retirement savings plan

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock-based long-term incentives

Paid time off / time-off programs

Flexible work models (remote and/orhy

Job summary

Amgen is seeking an Engineer I - Process Development to support development and implementation of technical solutions in the FDP GMP operations at AOH. You will manage complex projects spanning design, validation and scale-up, while collaborating across site networks to improve packaging capacity and performance.

The role requires strong teamwork, communication, and adaptability within a regulated environment, with opportunities for growth in a global biotech leader.

Qualifications

• Masters degree in a relevant field or demonstrated equivalent experience.
• GMP exposure with progressive responsibilities preferred.
• Ability to manage multiple complex projects in a regulated environment.
• Experience collaborating across cross-functional teams.
• Demonstrated track record of continuous improvement and problem solving.

Responsibilities

• Support development and implementation of technical solutions in FDP GMP ops.
• Coordinate complex projects involving design, validation, and scale-up.
• Provide technical operations support for packaging lines and process improvements.

Skills

Teamwork

Interpersonal skills

Communication skills

Adaptability

Operational excellence

Education

Masters degree

Bachelors degree + 2 years GMP

Associates degree + 6 years GMP

High school diploma / GED + 8 years GMP

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.

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.

Engineer I - Process Development

What you will do

Lets do this. Lets 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

• Masters degree


• OR


• Bachelors degree and 2 years of working in a GMP regulated environment


• Or


• Associates 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, 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, including remote and hybrid work arrangements, where possible

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.

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.