Amgen Inc.; Senior Engineer - R-239027; New Albany, Ohio; 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. 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. Position requires 2 years involving the following: 1. Applying engineering and scientific principles to bioprocess design and troubleshooting and investigations of bioprocess commercial production; 2. Utilizing knowledge of engineering principles for scale up of unit operations from bench to commercial scale; 3. Process Characterization and Technical Transfer to large-scale drug product sites, and Process Validation of bioprocess drug products; 4. Quality and regulatory systems including TrackWise, drug substance manufacturing, and process validation; 5. Applying problem-solving methodologies including fishbone diagrams and The Five Whys model to root cause analysis investigations; and 6. Identifying and evaluating process parameters and conducting statistical analysis using tools including JMP and Minitab.
Interested candidates email resume to Talent-Acquisition@amgen.com. Must reference Job # R-239027.
Job type: Full Time position. The annual salary range for this position in the U.S. is $123,098.00 - $149,145.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit https://careers.amgen.com/life-at-amgen/benefits/
