Senior Engineer

Amgen•New Albany, OH

About The Position

Join Amgen’s 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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Engineer What you will do and what we expect of you Let’s do this. Let’s change the world. In this vital role you will: Duties: Support the Technical Transfer of the Amgen product portfolio to Amgen Ohio; 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; 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; and Own the site master validation plan for GMP equipment and responsible to the maintenance and execution. Position requires up to 25% of travel to various unanticipated sites nationally and internationally.

Requirements

Master’s degree (or foreign equivalent) in Mechanical Engineering or related field & 2 years of experience in the job offered or in an engineering-related occupation
2 years involving applying engineering and scientific principles to bioprocess design and troubleshooting and investigations of bioprocess commercial production
2 years involving utilizing knowledge of engineering principles for scale up of unit operations from bench to commercial scale
2 years involving Process Characterization and Technical Transfer to large-scale drug product sites, and Process Validation of bioprocess drug products
2 years involving Quality and regulatory systems including TrackWise, drug substance manufacturing, and process validation
2 years involving applying problem-solving methodologies including fishbone diagrams and The Five Whys model to root cause analysis investigations
2 years involving identifying and evaluating process parameters and conducting statistical analysis using tools including JMP and Minitab

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
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
Serve as a 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 responsible for its maintenance and execution

Benefits

stock
retirement
medical
life and disability insurance
eligibility for an annual bonus
Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
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