Senior Engineer

Amgen; New Albany (OH); On-site; USD 115,000 - 156,000; Full time

Benefits offered by this job

Competitive benefits

Job summary

Amgen is seeking a Sr Engineer to serve as Line Owner/System Owner for packaging operations. You will apply engineering principles to optimize processes, lead design modifications, and coordinate cross-functional teams including Mechanics, Automation Techs, and IS staff.

As operations evolve to 24-hour coverage, you will participate in shift structures, drive problem solving, and support regulatory compliance across multiple equipment systems in a biotech manufacturing environment.

Qualifications

• Doctorate with packaging manufacturing or automation controls experience is required.
• Master’s degree and 2 years of packaging manufacturing or automation controls experience preferred.
• Bachelor’s degree and 4 years of packaging manufacturing or automation controls experience required.
• Associate’s degree and 8 years of packaging manufacturing or automation controls experience required.
• High school diploma/GED and 10 years of packaging manufacturing or automation controls experience required.

Responsibilities

• Owns technical aspects of a manufacturing line as Line Owner/System Owner.
• Apply engineering principles to design and implement system modifications.
• Interact with Mechanics, Automation Techs and IS teams for projects.
• Define design requirements for service providers to meet equipment needs.
• Support 24-hour operations by joining shift teams as needed.
• Audit equipment performance and regulatory compliance.

Skills

Pharmaceutical processes

Validation processes

Serialization knowledge

Documentation in regulated env

GMP understanding

Engineering in production

Problem solving

Project coordination

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

Career Category

Operations

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. Join us and transform the lives of patients while transforming your career.

Sr Engineer

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 were 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 including but are not limited to:

• The original work schedule for this role will be an administrative schedule (Monday through Friday, approximately 8 am to 5 pm). As the facility moves into operation, the successful incumbent will be expected to join a shift team structure working to support coverage across Amgen’s 24-hour operations. These shift structures can be a great opportunity to better support individual work / life priorities.
• 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 troubleshooting 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 significant 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.
• Obtain 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 unique contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications:

• Doctorate degree
• Master’s degree and 2 years of Packaging manufacturing or Automation controls experience
• Bachelor’s degree and 4 years of Packaging manufacturing or Automation controls experience
• Associate’s degree and 8 years of Packaging manufacturing or Automation controls experience
• High school diploma / GED and 10 years of Packaging manufacturing or Automation controls experience

Preferred qualifications

• Working 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 GMPs.
• Ability to apply engineering science to production.
• Able to develop solutions to routine technical problems of limited scope
• Comprehensive understanding protocol execution requirements.
• Problem solving and applied engineering.
• Basic technical presentations
• Personal Organization
• Protocol and script testing Writing
• Dealing with and handling change
• Packaging Equipment Technical knowledge
• Analytical Problem Solving
• Computer Literacy

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.

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

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.

Sponsorship

Sponsorship for this role is not guaranteed.

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.

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Salary Range

115,494.60USD -156,257.40USD