Engineer - System Owner

Amgen•New Albany, OH

About The Position

The Engineer - System Owner works under general supervision and owns the technical aspects of a manufacturing line. The role supports process characterization and optimization, resolution of operational issues in packaging and manufacturing operations, pilot technologies, and capital projects. It applies basic engineering principles to system modifications, experiments, and capital projects, and organizes, analyzes, and presents results for operational issues or engineering projects of limited scope and complexity. As a technical resource for an area, the System Owner/Line Owner Engineer interacts with and directs technical resources such as mechanics, automation technicians, and IS teams. The role also defines design requirements for service providers to meet area technical and equipment needs. In Operations Engineering, the engineer serves as a technical specialist for equipment or systems, supports daily operations to meet schedules or resolve problems, audits equipment and system performance and regulatory compliance, and collaborates with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance, and validation teams on system requirements and modifications. In Design Engineering, the engineer works under project managers to complete design, engineering, and construction projects within schedule and budget constraints. The role coordinates with consultants, architects, and engineering firms on standard design documents, evaluates quotes for equipment modifications or installations, and prepares basic project cost estimates and schedules.

Requirements

Master’s degree; or bachelor’s degree and 2 years of equipment experience in pharmaceutical, medical device, biotechnology, or related industries; or associate degree and 6 years of such equipment experience; or high school diploma/GED and 8 years of such equipment experience.
Ability to operate specialized equipment, tools, and computers as appropriate.
Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment.
Ability to apply engineering science to production.
Ability to develop solutions to routine technical problems of limited scope.
Comprehensive understanding of protocol requirements and validation protocol implementation requirements.
Organizational, project management, problem-solving, validation protocol, and technical writing capability.
Excellent verbal and written communication and presentation skills.
Interpersonal skills, including collaboration, influencing, and facilitation.
Protocol and script testing and writing skills.
Ability to deal with and handle change.
Packaging equipment technical knowledge.
Analytical problem-solving skills.
Knowledge of validation processes and requirements as applied to new equipment installations.

Nice To Haves

Advanced degree in mechatronics, computer, electrical, mechanical, or chemical engineering.
Knowledge and/or experience with pharmaceutical or biotechnology processes, especially final drug product operations.
Familiarity with validation processes for packaging areas.
Familiarity with serialization processes and networking.
Understanding of Operational Excellence and Lean Transformation in the automation and engineering context.

Responsibilities

Provide solutions to technical problems of moderate scope and complexity.
Evaluate, select, and apply standard engineering techniques and procedures under general supervision; seek assistance for unusual problems.
Perform assignments with clear objectives that require investigation of a limited number of variables.
Initiate and complete routine technical tasks.
Serve as a technical specialist for equipment or systems and solve operational problems.
Become actively involved in daily operations when needed to meet schedules or resolve problems.
Audit operational performance and regulatory compliance for a moderate number of equipment items or systems.
Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance, and validation departments to develop requirements and recommendations for system modifications.
Work under project managers to complete design, engineering, and construction projects within schedule and budget constraints.
Work with consultants, architects, and engineering firms to develop standard design documents.
Acquire and critique quotes for equipment modifications or installations.
Generate basic project cost estimates and schedules.
Interact with and provide direction to mechanics, automation technicians, and IS teams.
Define design requirements for service providers to fulfill area technical and equipment needs.
Characterize process optimization strategies and help resolve operational issues in packaging operations, manufacturing, pilot technologies, or capital projects.
Apply engineering principles to system modifications, experiments, and capital projects; organize, analyze, and present results.