R-182543 Process Development Associate Scientist

Join Amgen as a Process Development Associate Scientist in Juncos, where you will play a vital role in advancing our biopharmaceutical manufacturing processes. You will collaborate with a diverse team to drive innovative solutions and optimize production workflows in a dynamic environment.

Join our team as a Parenteral Process Scientist or Engineer, where you will play a pivotal role in optimizing pharmaceutical manufacturing processes. Your expertise in product validation, statistical analysis, and knowledge of automation will be essential during on-the-floor execution with formulation tanks. We are seeking a proactive individual who can ensure compliance with industry regulations while driving process improvements in parenteral and biological dosage forms.

Join Amgen as a Senior Associate in Technical Engineering, specializing in Process Mechanics. In this pivotal role, you will contribute to the design and optimization of our manufacturing processes, ensuring that we maintain the highest standards of quality and efficiency.

SUMMARYWorking under general supervision, you will be responsible for characterizing process optimization strategies and troubleshooting operational issues within the operations, manufacturing, pilot plant, or capital projects environments.You will apply fundamental engineering principles to design and implement system modifications, experiments, and capital projects.Your role will involve organizing, analyzing, and presenting results related to operational issues or engineering projects of moderate scope and complexity.FUNCTIONSDeliver effective solutions to a variety of technical problems that are moderate in scope and complexity.Evaluate, select, and apply standard engineering techniques and procedures under general supervision.Provide assistance for unusual problems that may arise.Complete assignments with clear and specific objectives, requiring the investigation of a limited number of variables.Initiate and finalize routine technical tasks efficiently.Operations Engineering:Act as a technical expert for equipment or systems related to troubleshooting operations. Frequently engage in daily operations as necessary to meet deadlines or resolve complex challenges.Conduct regular audits of operational performance and regulatory compliance for a moderate number of complex equipment items or systems.Collaborate with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance, and validation departments to develop requirements and recommendations for system modifications.Design Engineering:Work alongside project managers to successfully complete design, engineering, and construction projects within established schedules and budget constraints.Coordinate with consultants, architects, and engineering firms in the development of standard design documents.Request and evaluate quotes for equipment modifications or installations.Create preliminary project cost estimates and schedules.Additional responsibilities may be assigned as needed.

SUMMARYAs a Senior Engineer, you will independently lead the characterization of process optimization strategies while troubleshooting operational challenges within manufacturing, pilot plants, or capital project environments. You will leverage advanced and varied engineering principles to design and implement substantial system modifications, experiments, and capital projects. Your expertise will be critical in developing, organizing, analyzing, and presenting interpretations of results related to significant operational issues or engineering projects.FUNCTIONSGeneral:1. Undertake complex or novel assignments that necessitate the development of innovative engineering techniques and procedures.2. Establish engineering policies and procedures impacting multiple organizational units.3. Oversee, coordinate, and review the work of a small team of engineers, associates, and technicians on both an ongoing and project basis.4. Utilize advanced engineering techniques and/or adapt sophisticated techniques within your area of expertise.5. Apply a broad understanding of engineering principles and practices across varied assignments in related fields.6. Serve as a recognized specialist in engineering technology within at least one domain, holding overall responsibility for determining methodologies in that area.7. Apply mature engineering knowledge in the planning and execution of projects.Other functions may be assigned.Design Engineering:1. Develop innovative technical solutions to complex challenges requiring ingenuity and creativity.2. Collaborate with research, manufacturing, process development, utilities, facilities, quality assurance, and validation departments to formulate requirements and recommendations for significant system or facility modifications.3. Partner with project managers to ensure design and engineering projects are completed within schedule, budget, and quality standards.4. Coordinate consultants, architects, and engineering firms in creating standard design documentation.5. Formulate departmental or project budgets encompassing multiple disciplines for specific project areas or the entirety of smaller projects.

Join our dynamic team as a Commissioning & Qualification Consultant specializing in parenteral manufacturing and aseptic processes. In this role, you will provide critical support for the Validation, Commissioning, and Qualification of manufacturing processes and equipment in your assigned projects. Your expertise will extend to Aseptic Filling Processes, Media Fills, Environmental Monitoring, and various other projects as needed.

Join Amgen as a Senior Associate in Manufacturing Systems focusing on Automation. In this pivotal role, you will be integral to enhancing our manufacturing processes through advanced automation technologies, ensuring efficiency and compliance with industry standards.

Join Amgen as a Senior Associate in Manufacturing Systems where you will play a critical role in optimizing our manufacturing processes. You will collaborate with cross-functional teams to enhance operational efficiency and ensure compliance with industry standards.

Join Amgen as an AML14 Associate Manufacturing I in Juncos, where you will play a crucial role in supporting the manufacturing process. This position offers an exciting opportunity to work in a dynamic environment, contributing to life-saving therapies that improve patients' lives.

Join Amgen as a Senior Associate in Transportation, where you will play a crucial role in ensuring the efficient movement of goods and materials. In this position, you will collaborate with cross-functional teams to optimize transportation strategies and enhance operational efficiencies. Your contributions will directly impact our ability to deliver life-saving therapies to patients worldwide.

Join Amgen, a leading biopharmaceutical company, as an Associate Manufacturing I in Juncos. In this pivotal role, you will contribute to our mission of serving patients by ensuring high-quality manufacturing processes. Your work will be integral to our success in delivering innovative therapies that improve health outcomes.

Join Amgen as an Associate Manufacturing I in Juncos, Puerto Rico, where you will play a crucial role in supporting our manufacturing operations. This position offers a unique opportunity to be part of a dynamic team dedicated to producing high-quality biopharmaceutical products.

Join Amgen, a leading biotechnology company, as an AML14 Associate Manufacturing I in our Juncos facility. In this pivotal role, you will contribute to the manufacturing process, ensuring the highest quality standards are met. This is an exciting opportunity for individuals looking to launch their career in the biopharmaceutical industry.

Join Amgen as a Senior Associate in Data Analytics focused on Supply Chain. In this pivotal role, you will analyze data to support our supply chain operations, leveraging your analytical skills to drive efficiencies and improve processes. Collaborate with cross-functional teams to deliver actionable insights that enhance operational performance.

Join our team at Amgen as an AML14 Associate Manufacturing I in Juncos, where you'll play a crucial role in our manufacturing processes. As part of a dynamic team, you will contribute to the production of high-quality biopharmaceuticals that improve patient lives worldwide.

Join our dynamic team as a Quality Control Scientist, where you will play a pivotal role in the technical specialism of testing and development within the realms of molecular biology and microbiology. Operate under general supervision to address complex technical challenges that often span multiple organizations or sites, and engage with external resources as required.Your responsibilities encompass providing essential technical guidance, generating comprehensive reports, conducting data analyses, and facilitating effective communication among technical teams. You will also troubleshoot assay-related technical issues and ensure stringent lab compliance through the implementation of procedures that bolster GMP, GLP, and safety standards.In this role, you will manage existing programs while developing and implementing innovative processes and methodologies. You will also be tasked with revising and auditing complex controlled documents that may have widespread organizational impact, approving lab investigations, and leading audit teams. As a subject matter expert, you may assist in developing technical training and may supervise staff to meet technical requirements effectively.

SUMMARYThe Senior Engineer plays a pivotal role in independently characterizing and directing process optimization strategies, alongside troubleshooting operational challenges within manufacturing, pilot plants, or capital projects. Utilizing a diverse range of advanced engineering principles, this position focuses on the design and implementation of significant system modifications and experiments. The Senior Engineer is expected to develop, organize, analyze, and present interpretations of results pertaining to complex engineering projects and operational issues.FUNCTIONSGeneral Responsibilities:1. Execute complex assignments that necessitate the development of innovative engineering techniques and procedures.2. Formulate engineering policies and procedures impacting multiple organizational units.3. Lead, coordinate, and review the work of a focused team of engineers, associates, and technicians both on an ongoing basis and for specific projects.4. Employ advanced engineering techniques and modify these techniques within the area of expertise.5. Leverage knowledge of engineering principles across a broad array of assignments in related fields.6. Serve as a recognized specialist in engineering technology within at least one domain, responsible for determining methodologies in that area.7. Apply extensive engineering knowledge in the planning and execution of projects.Design Engineering Responsibilities:1. Craft technical solutions for intricate problems, utilizing ingenuity and creativity.2. Collaborate with research, manufacturing, process development, utilities, facilities, quality assurance, and validation departments to develop requirements and recommendations for complex system and facility modifications.3. Partner with project managers to deliver design and engineering projects adhering to schedule, budget, and quality standards.4. Coordinate efforts with consultants, architects, and engineering firms in creating standard design documents.5. Develop budgets for departmental or project expenses encompassing multiple disciplines for small-scale or comprehensive projects.EDUCATIONA Doctorate degree OR a Master’s degree with three years of engineering experience OR a Bachelor’s degree in Engineering with five years of engineering experience.PREFERRED QUALIFICATIONS:• Proficient understanding of pharmaceutical and biotech processes.• Familiarity with validation processes and documentation in regulated environments.• Experience operating specialized laboratory equipment and computers as necessary.• Ability to interpret and apply Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs).• Capable of applying engineering science in production contexts.• Strong analytical, troubleshooting, and advanced problem-solving skills.• Proficient in writing technical documents and developing detailed protocols.• Self-motivated with the ability to manage multiple tasks and collaborate effectively within teams.• Adaptable to dynamic work environments.

Join Amgen as a Senior Associate System Administrator, where you'll play a crucial role in maintaining and optimizing our IT systems. In this full-time position based in Juncos, you will collaborate with cross-functional teams to ensure system reliability and performance. Your expertise will contribute to our mission of delivering innovative solutions in the biotechnology sector.

Join Amgen as a Senior Associate in Quality Assurance, focusing on Anti-Money Laundering (AML) processes. This full-time position in Juncos provides an exciting opportunity to enhance your career while ensuring compliance and quality standards are met. You will play a crucial role in maintaining the integrity of our AML operations and contribute to the overall success of our quality assurance team.

Join Amgen, a leading biotechnology company, as a Senior Associate in Quality Assurance (QA) focused on Anti-Money Laundering (AML). In this role, you will play a critical part in ensuring compliance and quality control within our processes. Your expertise will contribute to maintaining the integrity of our operations while adhering to regulatory standards.