Senior Process Development Engineer- Packaging Equipment

Senior Process Development Engineer - Packaging Equipment

Join Amgen 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 lie 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

Lets do this. Lets change the world. In this role the Senior Engineer I position reports into the Sr, Manager of Process Development. 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.

The position is expected to travel for approximately 20%.

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 you must manage and/or apply extensive technical expertise (characterization, validation and troubleshooting) in the assembly 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 Technical Transfer of the Amgen product portfolio. 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 collaborators 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. You will be 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.

You will also be responsible for leading the Commissioning, Qualification and Validation of process and GMP equipment. They will own the site master validation plan for GMP equipment and will be responsible to the maintenance and execution of this.

Operational Excellence

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

Relationships

The Senior Engineering is expected to build a network of FDP expertise across the Amgen commercial and clinical operations for product assembly, label and packaging. The position is expected to bring to bear this network in support of GMP technical expertise, performance trending, equipment standardization and troubleshooting/process improvements.

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

Doctorate degree

OR

Masters degree and 2 years of GMP regulated environment experience

Or

Bachelors degree and 4 years of GMP regulated environment experience

Or

Associates degree and 8 years of GMP regulated environment experience

Or

High school diploma / GED and 10 years of GMP regulated environment experience

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 team work, 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.

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