Engineer - System Owner

Amgen•New Albany, OH

3d•$88,281 - $119,439

About The Position

The Engineer - System Owner (also referred to as Line Owner/System Owner Engineer) works under general supervision and owns the technical aspects of a manufacturing line. The role supports process characterization and optimization, resolves operational issues in packaging operations, manufacturing, pilot technologies, or capital projects, and applies engineering principles to system modifications, experiments, and projects. The engineer analyzes and presents results related to operational issues and engineering projects of minor scope and complexity. As an area technical resource, the engineer interacts with and provides direction to mechanics, automation technicians, and Information Systems teams, and defines design requirements for service providers addressing technical and equipment needs. The role includes operations engineering work and design engineering work, including equipment problem solving, performance and compliance audits, cross-functional development of system modification recommendations, and support for design, engineering, and construction projects. The position requires a qualifying combination of education and equipment experience. Preferred qualifications include relevant engineering education and experience with pharmaceutical or biotechnology processes, packaging equipment, validation, serialization, regulated documentation, and applicable engineering and quality practices.

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.
Ability to apply engineering science to production.
Ability to develop solutions to routine technical problems of limited scope.
Comprehensive understanding of protocol requirements.
Organizational, project management, problem-solving, validation protocol, and technical writing capabilities.
Excellent verbal and written communication and presentation skills.
Interpersonal skills, including collaboration, influencing, and facilitation.
Ability to write and test protocols and scripts.
Ability to deal with and handle change.
Analytical problem-solving ability.

Nice To Haves

Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering.
Knowledge of 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.
Familiarity with documentation in a highly regulated environment.
Packaging equipment technical knowledge.
Comprehensive understanding of validation protocol implementation requirements and knowledge of validation processes and requirements for new equipment installations.
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, solving operational problems and becoming involved in daily operations when needed to meet schedules or resolve issues.
Routinely audit the operational performance and regulatory compliance of 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' direct supervision 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 Information Systems teams.
Define design requirements for service providers to address area technical and equipment needs.

Benefits

Health and welfare plans for staff and eligible dependents.
Retirement and savings plan with company contributions.
Group medical, dental, and vision coverage.
Life and disability insurance.
Flexible spending accounts.
Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
Stock-based long-term incentives.
Award-winning time-off plans.
Flexible work models, including remote and hybrid arrangements where possible.
Career development opportunities.