Amgen Rhode Island is one of the premier biologics drug substance manufacturing sites in the world with a long history of operational excellence and highly successful commercial and clinical operations.
We are looking for a talented Manufacturing Specialist to help deliver opportunities for reliability, efficiency, agility and differentiation for the AR5 and AR30 Manufacturing plant.
This individual contributor position reports into the Senior Manager of the Investigation and Training team and interacts broadly across the site to implement key business deliverables, quality initiatives, and continuous improvement projects within the AR5 and AR30 plants. This role will focus on supporting manufacturing training on and off the floor, and supporting the site major investigations. The flexibility to support all four shifts covering 24/7 operations is a requirement. The successful candidate will conduct technical investigations for our clinical and commercial Drug Substance Operations and is responsible to understand the investigation process as well as the manufacturing processes for the Amgen Rhode Island Facility. In this role, the Mfg. Specialist will maintain close interactions with the Manufacturing leads, Engineering, Process Development, Quality Controls, Supply Chain, and Quality functions to mitigate product impact and contribute to product/process improvement.
Be able to perform major investigations record at the site Managing meeting, sending minutes, RCA, identification of CAPA, and development of a deviation report.
Supporting Training improvements across both manufacturing plants
Support the training Center (Material availability, training coordination, housekeeping and area safety)
Support the development and execution of the cross-training strategy and Rapid onboarding
Providing training expertise for area of responsibility
Be able to support the investigation team
Trouble shooting and problem-solving support to manufacturing
Identifying and autonomously implementing continuous improvement opportunities
Owning and implementing corrective/preventative actions
Supporting Manufacturing specialists during complex investigations and change controls
Owning and authoring SOPs
Providing data to support management evaluation of performance trends
Applies knowledge and subject matter expertise to ensure end-to-end of investigations
Lead discussion to reduce, correct, mitigate and prevent the reoccurrence of the event based on output of root cause analysis.
Perform trend investigations, including statistical assessment of data to identify trends, as well as generation of reports.
Perform notification of potential product impact.
Advise management on investigation progress, product/ process risk, and potential delays.
Support functional management initiatives and objectives
Anticipates and prevents potential issues with regulators
Own and/or Drive Improvement projects/initiatives
Collaborate cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures.
Alert senior management of quality, compliance, supply and safety risks.
Masters degree and 3 years of Manufacturing or Operations experience
Bachelors degree and 5 years of Manufacturing or Operations experience
Associates degree and 10 years of Manufacturing or Operations experience
High school diploma / GED and 12 years of Manufacturing or Operations experience
5+ years of demonstrated ability in investigation process.
Strong technical writing
Proven Six Sigma proficiency specifically for root cause analysis methodology
Understanding and application of Drug Substance process, data mining, quality and compliance.
Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Project Management experience
Able to influence tri-functional team and organizational leads
Familiarity with the training development and facilitation
- Experience owning and editing standard operating procedure
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, or disability status.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.