Engineer - System Owner

Amgen; New Albany (OH); Hybrid; USD 88.000 - 119.000; Vollzeit

Zusammenfassung

Amgen seeks an Engineer - System Owner to lead technical aspects on a manufacturing line. You will coordinate with Mechanics, Automation, and IS teams, applying engineering principles to design and implement system modifications and capital projects.

Responsibilities include problem solving, evaluating standard techniques, and delivering on routine technical tasks. The role supports operations, design, and cross-functional collaboration in a regulated environment.

Qualifikationen

• Master’s degree in a related field with equipment experience in pharma/biotech.
• Bachelor’s or higher with specified equipment experience in Pharmaceutical, Medical Devices, Biotechnology, or related industries.
• Equivalent combinations with HS diploma and years of equipment experience accepted.

Aufgaben

• Provide solutions to technical problems of moderate scope.
• Evaluate and apply standard engineering techniques under supervision.
• Assist with unusual problems and routine technical tasks.
• Interact with mechanics, automation techs and IS teams.

Kenntnisse

Analytical problem solving

Communication skills

Team collaboration

Documentation

Process understanding

Ausbildung

Master’s degree

Bachelor’s degree + 2 years Equipment experience

Associate’s degree + 6 years Equipment experience

High school diploma/GED + 8 years Equipment experience

Tools

Validation protocols

GAMPs/GMPs knowledge

Jobbeschreibung

Career Category Engineering Job Description

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Transform the lives of patients while transforming your career.

Engineer - System Owner

What you will do Let’s do this. Let’s change the world. In this role, the Line Owner/System Owner must work under general supervision, owns all the technical aspects in a manufacturing line. The processes the SO/LO Engineer shall be familiar with are: characterization of process optimization strategies and/or solving problems of operational issues in the packaging operations, manufacturing, pilot technologies or capital projects. Applies 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. As a technical resource of an area, System owner / Line Owner Engineer shall interact and provide direction to technical resources such as Mechanics, Automation Techs and IS teams. At the same time, the System Owner/Line Owner Engineer shall be able to define designs requirement to the service providers to fulfill area technical and equipment needs.

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.

Operations Engineering: Function as a technical specialist to equipment or systems regarding problem solving operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve problems. Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of complexity.

Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.

Design Engineering: 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. Acquire and critique quotes for equipment modifications or installations. Generate rudimentary project cost estimates and schedules.

What we expect of you

What we expect of you. We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications:

• Master’s degree
• Bachelor’s degree and 2 years of Equipment experience in Pharmaceutical, Medical Devices, Biotechnology, or related industries
• Associate’s degree and 6 years of Equipment experience in Pharmaceutical, Medical Devices, Biotechnology, or related industries
• High school diploma/GED and 8 years of Equipment experience in Pharmaceutical, Medical Devices, Biotechnology, or related industries

Preferred Qualifications:

• Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering
• Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations
• Knowledge of pharmaceutical/biotech processes
• Familiarity with validation processes for Packaging areas
• Familiarity with serialization process and networking
• Familiarity with documentation in a highly regulated environment
• 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.
• Able to develop solutions to routine technical problems of limited scope
• Comprehensive understanding of protocol requirements.
• Organizational, project management, problem-solving, as well as validation protocol, and technical writing capability
• Excellent communication (verbal/written) and presentation skills
• Demonstrated interpersonal skills including; collaboration, influencing, and facilitation
• Protocol and script testing
• Writing
• Dealing with and handling change
• Packaging Equipment Technical knowledge
• Analytical Problem Solving
• Comprehensive understanding of validation protocol implementation requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
• Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Context

What you can expect of us

What you can expect of us. As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

Benefits and Compensation

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

Salary Range 88,281.00USD -119,439.00 USD

Sponsorship

Sponsorship for this role is not guaranteed. In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Equal Opportunity Employer

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. 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, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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 biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen