Senior Engineer

Senior Engineer Responsibilities

• Support the Technical Transfer of the Amgen product portfolio to Amgen Ohio
• Provide technical operations support for the continuous improvement of device assembly and packaging line capacity and performance, and advise on technical improvement projects
• Ensure communication throughout the Amgen Ohio commercial site and Amgen network with all partners and deliver on technical deliverables
• Act as the site technical expert for automated and semi-automated device assembly for FDP and non‑combination products
• Technical expert for new process and existing device assembly technology
• Use technical process knowledge and identify the required expertise to resolve process challenges
• Utilize technical expertise in combination product assembly
• Lead the commissioning, qualification and validation of process and GMP equipment
• Own the site master validation plan for GMP equipment and be responsible for the maintenance and execution

Position requires up to 25% travel to various unanticipated sites nationally and internationally.

Candidates must hold a master's degree in Mechanical Engineering or a related field and have at least two years of experience in an engineering‑related occupation, plus two years experience applying the following.

• Applying engineering and scientific principles to bioprocess design and troubleshooting and investigations of bioprocess commercial production
• Utilizing knowledge of engineering principles for scale up of unit operations from bench to commercial scale
• Process characterization and technical transfer to large‑scale drug product sites, and process validation of bioprocess drug products
• Quality and regulatory systems, including Track Wise, drug substance manufacturing, and process validation
• Applying problem‑solving methodologies, including fishbone diagrams and the Five Whys model, to root cause analysis investigations
• Identifying and evaluating process parameters and conducting statistical analysis using tools such as JMP and Minitab

Full‑time position. Salary range: $123,098 – $149,145 per year. Additional benefits: stock, retirement, medical, life and disability insurance, and eligibility for an annual bonus or incentive compensation.

• 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

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.