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Engineer

2 months ago


Thousand Oaks, United States Actalent Full time

Description:

Hybrid Location - supporting ATO - Flexible with 2-3 days onsite

Ideal candidate: 3 YOE in field desired with bachelors. Experience working in a regulated industry exposure to GMPs Medical Device experience is highly desired. Mathematical fundamentals of statistics. Useful to have exposure to test method development CAD design Solidworks mechanical modeling. Nice to have: programming R and python experience. hands on technical experience useful comfortable working within a lab.

Job Details: Position involves support of staff in the initiation design and delivery of projects particularly for automation related projects in the Process Development Organization within the Combination Product Operations. The candidate will be a part of the Commercial Platform Methods and Automation team where the responsibilities include lifecycle management of Physical GMP Test Methods lifecycle management of integrated testing machines development and validation of test methods. The successful candidate employs basic engineering skills and practices to gather user requirements and translate them into technical documentation. Assist with project definition by performing engineering studies and assessment for automated test systems installations. Perform field evaluations of existing systems and provide engineering design recommendations.

The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables. This individual has a passion for modeling analytics and technology. The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions.

This may include but is not limited to the following:

Collaborate with Engineers using the system to edit develop and run automated experimental protocols.

Knowledge on Equipment and Method validation principles generation of Lifecycle Documentation such as FAT/SAT IQ/OQ equipment characterization protocols Gauge Repeatability and Reproducibility studies.

Troubleshooting of various lab instruments and automation systems which will require learning the specific software controlling the instruments and integrated systems from vendor manuals and site documents.

Assisting Engineers to successfully develop transfer and execute processes on the integrated platforms and equipment.

Developing enhancing automating and managing test data.

Network with manufacturing and quality organizations internal to Amgen.

Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards accurately documented per SOPs.

Monitoring technological developments in the field evaluation of new technologies.

Preferred Skills

Experience working in a regulated industry exposure to GMPs.

Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership.

Statistical analysis and knowledge of Gage RR

Knowledge of Optical measurement devices force testers BLE testing.

best method development CAD design SolidWorks mechanical modeling.

Manufacturing experience IQ OQ and PQ.

Preferred Traits:

passion for proactively identifying opportunities through creative data analysis and modeling.

Intellectual curiosity with ability to learn new concepts/frameworks algorithms and technology rapidly as needs arise.

Ability to manage multiple competing priorities simultaneously.

Skills:

gage rr, programming, python

Top Skills Details:

gage rr,programming,python

Experience Level:

Entry Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

+ Hiring diverse talent

+ Maintaining an inclusive environment through persistent self-reflection

+ Building a culture of care, engagement, and recognition with clear outcomes

+ Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.