The Engineer will support Process Development – System Owner area. With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. This role is crucial for Amgen’s success and will be a key contributor in Process Development Drug Substance organization.
Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, or capital projects environment. Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.
SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
Provide solutions to a variety of technical problems of moderate scope and complexity.
Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
Initiate and complete routine technical tasks.
Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity.
Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
Work with consultants, architects and engineering firms on development of standard design documents.
Obtain and critique quotes for equipment modifications or installations.
Generate rudimentary project cost estimates and schedules.
Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments.
Support non-standard shift organization and extended hours, as per business needs.
Master’s degree in Engineering
Bachelor’s degree in Engineering & 2 years of Manufacturing and/or Process Development experience in GMP regulated industry
Education background in Mechanical and/or Electrical Engineer.
Working knowledge of pharmaceutical/biotech processes.
Detailed technical understanding of bio-processing unit operations.
Skilled in performance of GMP production operations.
Regulatory knowledge and interactions.
Organizational, technical writing and presentation skills.
Project management skills.
Knowledge of and experience in the Maximo (CMMS) system.
Knowledge of control charting.
Excellent communication skills in English and Spanish.
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 people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.