What are the responsibilities and job description for the Engineer position at BioSpace?
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. 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
What You Will Do
Lets do this! Lets change the world! In this vital role you will [top-line statement connecting primary position responsibility to employer brand].
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications
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
careers.amgen.com
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.
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. 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
What You Will Do
Lets do this! Lets change the world! In this vital role you will [top-line statement connecting primary position responsibility to employer brand].
- Adheres to strict documentation practices in a GMP regulated environment
- Engineering competency in all conventional aspects of the subject matter, functional area, and assignments
- Plans and performs work, independently evaluating, selecting, and adapting standard methods, and creating new solutions to engineering problems.
- Authors and reviews technical documentation including protocols, reports, and technical assessments
- Coordinates and executes laboratory testing to support characterization, verification, and design transfer activities
- Analyzes and trend generated data by applying relevant statistical techniques
- Maintains device and combination product design history files for assigned products
- Ensure test methods and test protocols are developed in a sound and robust framework with high focus on eliminating test errors
- Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
- Lead teams in the implementation for process improvement initiatives
- Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications
- Provides training and ongoing support to team members and internal stakeholders on the use of digital tools, promoting continuous learning and development within the team.
- Oversees the maintenance of a digital thread across testing and data analytics, ensuring comprehensive integration and accessibility of data throughout combination product.
- Utilizes and drives Agile project methodologies throughout the project lifecycle, ensuring flexible, efficient, and effective project management and implementation.
- Engages with internal and external stakeholders to understand their challenges and requirements, tailoring digital solutions to meet these specific needs.
- Executes complex data queries to extract, clean, and manipulate data from various sources, ensuring the data is usable for detailed analysis and reporting.
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications
- High school diploma / GED and 8 years of engineering experience OR
- Associates degree and 6 years of engineering experience OR
- Bachelors degree and 2 years of engineering experience OR
- Masters degree
- Bachelors Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
- Experience with Final Drug Product and/or Drug Product, medical device development, commercialization and manufacturing processes
- Experience with design controls; including, but not limited to, design verification and transfer
- Experience with investigations and quality records
- Statistical Analysis software (Minitab or JMP)
- Experience with Instron force testers using BlueHill Universal
- Test method development, GR&R, and text fixture design
- Ability to work independently and dynamically across functional teams
- Strong technical writing and verbal communication skills including technical presentations (i.e., PowerPoint)
- Experience complying with applicable standards and regulations: (i.e. 21CFR820.30, ISO 13485)
- Team leadership and project management aptitude
- Familiarity with change control and deviation management systems (e.g. TrackWise and DQMS).
- Familiarity with Agile methodologies and experience managing projects using Agile to ensure flexible and efficient project delivery.
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
careers.amgen.com
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.
