The System Owner, provides and/or directs technical expertise and acts as technical subject matter expert for Drug Product aseptic area manufacturing equipment's. Performs troubleshooting of operational issues and provides highly efficient engineered solutions.
Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant 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.
Prompt and regular attendance to workplace.
Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
Develop engineering policies and procedures that affect multiple organizational units.
Coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization.
Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
Applies engineering knowledge into planning and conducting projects. Prompt and regular attendance to workplace
BASIC EDUCATION/ EXPERIENCE
Doctorate degree in Engineering
Master's degree in Engineering and 3 years of aseptic manufacturing equipment/process related experience
Bachelor's degree in Engineering and 5 years of aseptic manufacturing equipment/process related experience.
Educational Background in Electrical or Mechanical Engineering
Available on standard and non-standard shift as required
Working knowledge of pharmaceutical/biotech processes
Adheres to company policies and procedures to ensure a continuous state of compliance
Familiarity with documentation in a highly regulated environment
Ability to interpret and apply GMPs
Direct experienced in Quality Systems, Non Conformance, CAPA, Change Control
Provides support to regulatory audits as technical expert and presenter
Experience in troubleshooting of highly automated systems / equipment
Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and problems resolutions approach
Ability to apply engineering science to production
Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
Able to develop solutions to routine technical problems
Ability to independently determine when additional external resources are required to solve problems
Monitors and address equipment failure trending
Monitors and develops an efficient reliability program
Establishes effective corrective and preventive actions on systems and equipment
Handle middle to large complex projects and assist in the generation of required evaluations and permits
Ability to handle multiple projects/priorities simultaneously at one time
Ability to delegate and manage the project work of others
Create, interpret, modify, revise and approve technical documents such as Standard Operating Procedures, Design Specifications, P&IDs, flowcharts, etc.
Ability to utilize CMMS (MAXIMO) system, as a maintenance tool in regulated environments
Assists in the maintenance activities planning
Evaluates equipment maintenance scope and develops the required changes for an optimum equipment performance
Expert in condition based maintenance technologies such as: Vibration, thermography and ultrasound monitoring, and evaluation
Familiarity with equipment validation requirements and processes
Demonstrated skills in the following areas:
Technical knowledge in the Drug Product manufacturing processes and equipment (Component Prep, Formulation and/or filling)
Basic Technical report writing
Comprehensive understanding of validation protocol execution requirements.
Demonstrated Skills in the following areas:
Analytical Problem Solving
Effective verbal and writing communication
Able to interact effectively with variety of communications and working styles
Successful delivery of Basic technical presentations
Dealing with and managing change
Demonstrated Project Management Skills in the following areas:
Basic project management
Project cost development
Negotiation, persuasion and facilitation
Leadership and team building
Management of contractors and vendors
Completion and follow-up
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient.
Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.