Sr. Engineer - Process Development (Commissioning, Qualification, and Validation)

Overview

Sr. Engineer - Process Development (Commissioning, Qualification, and Validation) role at Amgen. The position supports commercial GMP Final Drug Product (FDP) operations at the Amgen Ohio facility.

What You Will Do

The Senior Engineer reports to the Sr. Manager of Validation. This role applies diverse and advanced engineering and scientific principles to support FDP operations at the Amgen Ohio facility.

Functions

• Support the development and implementation of automated and semi-automated device assembly equipment initiatives as part of the Finished Drug Product (FDP) portfolio at the Amgen Ohio site.
• Lead qualification and validation efforts for combination products and related processes, applying advanced engineering principles across process, unit operations, equipment, devices and materials for complex process optimization.

Outputs

Support Qualification and Validation of the Amgen product portfolio to AOH. Provide technical operations support for continuous improvement of device assembly and packaging line capacity and performance, and advise on technical improvement projects. Ensure effective communication with stakeholders across the Amgen Ohio site and network.

Act as site technical expert for automated / semi-automated device assembly for FDP and non-combination products. Serve as the technical lead for new process and existing device assembly technology. Resolve process challenges with appropriate expertise; experience in combination product assembly is required.

Support productivity, throughput, and capacity improvements by analyzing and implementing manufacturing and business process improvements at the AOH site.

What We Expect Of You

We seek a CQV professional with the following qualifications and mindset.

Basic Qualifications

Preferred Qualifications

What you can expect from us

Competitive benefits and a collaborative culture supporting your professional and personal growth. Salaries vary based on skills and experience. Amgen offers a Total Rewards Plan including health and welfare plans, retirement savings, work / life balance, and career development opportunities.

Equal Opportunity

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. Reasonable accommodations are available to applicants with disabilities for the interview process and to perform essential job functions. For accommodation requests, please contact Amgen.

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