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Engineer (JP12205C)

3 Key Consulting

Camberige, MA | Full Time

$102k-124k (estimate)

4 Months Ago

Engineer (JP12205C)

3 Key Consulting Camberige, MA

$102k-124k (estimate)

Full Time | Business Services 4 Months Ago

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3 Key Consulting is Hiring an Engineer (JP12205C) Near Camberige, MA

Job Title: Engineer (JP12205C)Location: Cambridge, MA. OR Thousand Oaks, CA.Business Unit: Physical Methods Development, Modeling and Emerging MethodsEmployment Type: ContractDuration: 2 years (with possible extensions)Rate: $38 - $42Posting Date: 1/26/2024Notes: 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 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 client
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

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 experiencePreferred 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 teamRed 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 send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$102k-124k (estimate)

POST DATE

01/29/2024

EXPIRATION DATE

06/26/2024

WEBSITE

3keyconsulting.com

HEADQUARTERS

WEST HILLS, CA

SIZE

100 - 200

FOUNDED

2009

TYPE

Private

REVENUE

$50M - $200M

INDUSTRY

Business Services

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