Career CategoryEngineering
Job DescriptionEngineerWhat you will doLet's do this. Let's change the world. In this vital role you will working in Combination Products Operation - Manufacturing Science and Technology, is responsible for engineering activities required for the development / qualification / validation and transfer of physical GMP test methods for combination products, devices, primary containers, and secondary packaging components. The Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product, processes, tooling or equipment introduction to improve quality and reliability and reduce cost. Phases of projects include: developing combination product test methods, providing key expert support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support.
Responsibilities- Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
- Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements.
- Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
- Implement projects per Combination Products Operation and company procedures to ensure projects are completed on schedule and within established budget.
- Provide expert support for investigations as well as new process development required to improve manufacturing operations.
- Coordinate test method development and delivery with selected contractors.
- Ensure that qualification parameters are met for product assembly requirements.
- Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
- Generate procedures necessary to support department and new process equipment.
- Provide expert training to individuals in the operation and maintenance of processes, test methods and equipment introduced to Quality Control and/or the manufacturing department (i.e. production operator, mechanics, process engineers).
- Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams).
- Generate/author and own the Test Method documents.
- Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design
- Perform other duties as required by the Group Manager
- Comply with the requirements, responsibilities, and authority as required
- Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals
- Networks internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects
- Networks with manufacturing, quality and regulatory organizations both internal and external to Amgen
- Drives the cross-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle
- Excellent verbal and written communication skills are utilized to communicate project status and risks associated with integrated timelines to leadership
- Collaborates with other functional leaders to ensure project success, momentum and commitment
- Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently
- Integrates partner/vendor timelines with Amgen timelines as appropriate
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. Engineer professional we seek is an individual with these qualifications.
Basic Qualifications:Master's degree
OR
Bachelor's degree and 2 years of engineering/scientific experience
OR
Associate's degree and 6 years of engineering/scientific experience
OR
High school diploma / GED and 8 years of engineering/scientific experience
Preferred Qualifications:- M.S. in Mechanical Engineering, Chemical or Biomedical Engineering, or Chemistry
- Excellent written and verbal communication skills
- Ability to work in a highly matrixed team environment
- 2 years of experience in the biotechnology/pharmaceutical industry
- 2 years of experience in equipment, method, and mechanical design
- Technical writing experience
- Experience with SolidWorks (or other 3D-CAD software)
- Experience with combination products and regulatory requirements
- Experience utilizing Minitab (or other statistical software packages)
What you can expect of usAs 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.
This role is paid hourly. The expected annualized salary range for this role in the U.S. (excluding Puerto Rico) is $xxx,xxx.00 to $xxx,xxx.00. 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.
Salary Range88,281.00USD -119,439.00 USD
