Sr Engineer Process Development - New Albany OH

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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.

What you will do

Let's do this. Let's change the world. In this role the Senior Engineer position reports to the Sr, Manager of Validation. 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 facility.

Functions

The Senior Engineering will support the development and implementation of automated and semi-automated combination product assembly equipment initiatives as part of the Finished Drug Product (FDP) product portfolio at the Amgen Ohio manufacturing site. The position is a key role in the Process Development team where the candidate must manage and/or apply extensive technical expertise in the qualification and validation of combination products. This position will also be required to apply advanced and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process optimization, scale up and manufacturing support projects.

Outputs

Project Management

Key responsibilities will include supporting the Qualification and Validation of the Amgen product portfolio to AOH. Additional responsibilities will include the provision of technical operations support for the continuous improvement of device assembly and packaging line capacity and performance, and advisory of technical improvement projects. The Sr. Engineer must ensure effective communication throughout the Amgen Ohio commercial site and Amgen network with all stakeholders and deliver on technical deliverables.

Technical Lead

Act as the site technical expert for automated and semi-automated device assembly for FDP and non-combination products. Be the technical expert for new process and existing device assembly technology. The candidate is expected to use technical process knowledge and identify the required expertise to resolve process challenges as needed. Technical expertise in combination product assembly is required.

The candidate will also be responsible for conducting the Commissioning, Qualification and Validation of process and GMP equipment located at AOH. They will own the site master validation plan for GMP equipment and will be responsible for the maintenance and execution of this.

Operational Excellence

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

Additional Qualifications/Responsibilities

What we expect of you

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

Basic Qualifications:

Doctorate degree

OR

Master's degree and 2 years of working in a GMP regulated environment

Or

Bachelor's degree and 4 years of working in a GMP regulated environment

Or

Associate's degree and 8 years of working in a GMP regulated environment

Or

High school diploma / GED and 10 years of working in a GMP regulated environment

Preferred Qualifications:

Knowledge of combination product assembly equipment and applicable testing.

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.

Strong teamwork, excellent interpersonal and communication skills.

Direct experience with the manufacturing process for devices, combination products and label & packaging operations.

Experience of working with Final Drug Product 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!