Job Title: Engineer

Location: Thousand Oaks, Ca

Duration: 24 Months with possible extension

Tax Term: W2

Job Diva Id: 25-31031 (Client’s Id pending)

Standard business hours

Description:

**This is a Hybrid role

***Hiring Manager Intake Notes**

· What location will this position be tied to? Thousand Oaks (ATO)

· Will there be any opportunity for remote work? This is a Hybrid position. 2 days on site and 3 days work from Home. This might vary depending on projects and business needs.

· What are the exact shift hours/schedule the contractor will be working/reporting? 8AM-5PM PT- Amgen Core Business hours

· What type of qualities/characteristics are you looking for in candidates to work best with your team? Someone who is motivated to work both individually and in a team.

· When reviewing resumes, what stands out to you when looking for the right applicants? Previous projects/job experience.

· What is your minimum education and years of work experience you think it most suitable for this role? Minimum education in BS in Mechanical/Biomedical Engineering with 1-3 years of experience preferably in Pharmaceutical/Biomedical industry.

Top Must Have Skill Sets:

• Statistical analysis, and knowledge of Gage R&R,

• Knowledge of Optical measurement devices, force testers, BLE testing

• Test method development, CAD design, Solidworks, mechanical modelling

Job Details: Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization. Responsibilities include development and 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

• 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 R&R,

• Knowledge of Optical measurement devices, force testers, BLE testing

• Test 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, experience with MS Project, Smartsheet

Basic Qualifications:

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Day to Day Responsibilities:

Support FTE Engineers developing Methods and performing testing

Create and revise documentations