Senior Process Development Engineer- Packaging Equipment

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. As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Process Development Engineer- Packaging Equipment

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%

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 trouble shooting) in the assembly of combination products. 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 optimization, scale up and manufacturing support projects.

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.

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.

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.

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 trouble shooting/process improvements.

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.
• 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!

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

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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.

Salary Range