drjobs Engineer JP12205T

Engineer JP12205T

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1 Vacancy
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Job Location drjobs

Thousand Oaks, CA - USA

Monthly Salary drjobs

$ 38 - 42

Vacancy

1 Vacancy

Job Description

Job Title: Engineer (JP12205T)
Location: Thousand Oaks CA. 91320 Or Cambridge MA.
Business Unit: Physical Methods Development Modeling and Emerging Methods
Employment Type: Contract
Duration: 2 years (with possible extensions)
Rate: $38 $42
Posting Date: 1/26/2024.
Notes: Only qualified candidates need apply.


3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client a leading global biotechnology company.

Job Description:
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 wellconstructed 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 client
  • Ensuring all tasks and responsibilities are performed according to industryleading scientific standards & accurately documented per SOPs
  • Monitoring technological developments in the field & evaluation of new technologies

The ideal candidate will have:
  • 3 YOE in field desired with bachelors
  • Experience working in a regulated industry.
  • Exposure to GMPs
  • Medical Device experience is highly desired.
  • Mathematical background 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 in a lab.

Top Must Have Skill Sets:
  • Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
  • Ability to manage multiple competing priorities simultaneously
  • Statistical analysis and knowledge of Gage R&R

Day to Day Responsibilities:
  • Develop and support lifecycle management of physical test methods and associated documentation(test method protocols SOPs training documents etc.
  • Execute test method protocols analyze data
  • Maintain projects status and communicate with client internal clients
  • Employee Value Proposition:

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

Preferred Qualifications:
  • 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

Why is the Position Open
Supplement additional workload on team

Red Flags:
  • Is not local and cannot commit to onsite work.
  • No Bachelors.
  • Not a document review role not interested in candidates with background in QC or QA experience only.
  • No interested in lab work setting.

Interview Process:
One phone and one virtual panel interview.

We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.

Employment Type

Full Time

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