Engineer - System Owner

BioSpace; New Albany (OH); Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

Retirement plan

Stock incentives

Paid time off

Flexible work options

Job summary

Amgen is seeking a System Owner/Line Owner Engineer to manage all technical aspects on a manufacturing line. The role involves coordinating with Mechanics, Automation Techs and IS teams, and defining design requirements for service providers to meet equipment needs.

The work requires applying engineering principles to improvements and capital projects. The successful candidate will contribute to packaging operations, process optimization and problem solving in a regulated environment, with

Qualifications

• Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering preferred.
• Knowledge of pharma/biotech processes, especially final drug product operations.
• Familiarity with validation processes for packaging areas and serialization.

Responsibilities

• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Evaluate and apply standard engineering techniques under supervision for routine projects.
• Interact with Mechanics, Automation Techs and IS teams to meet equipment needs.
• Prepare rudimentary project cost estimates and schedules.

Skills

Analytical skills

Communication skills

Interpersonal skills

Engineering knowledge

Education

Masters degree

Bachelor's degree + 2 years equipment experience

Associates degree + 6 years equipment experience

High school diploma/GED + 8 years equipment experience

Tools

GAMPs & GMPs

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Engineer - System Owner

What you will do

Lets do this. Lets 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

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

Basic Qualifications

• Masters degree
• Or
• Bachelors degree and 2 years of Equipment experience in Pharmaceutical, Medical Devices, Biotechnology, or related industries
• Or
• Associates degree and 6 years of Equipment experience in Pharmaceutical, Medical Devices, Biotechnology, or related industries
• Or
• 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

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, well support your journey every step of the way.

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

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.

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.