Engineer GMP Drug Delivery Medical Device JP13653C
Engineer GMP Drug Delivery Medical Device JP13653C
Posted on :
11-04-2025
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1 Vacancy
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Job Description
Job Title:Engineer GMP Drug Delivery Medical Device (JP13653C)
Location:Cambridge MA 02138 OR Thousand Oaks Ca.
Business Unit:Physical Methods Development Modelling and Emerging Method
Employment Type: Contract
Duration:12 months with likely extensions or conversion to perm
Rate: 3842$/hours W2 with benefits
Posting Date:1/27/2025
Target Start Date:2/24/2025
3 Key Consulting is hiring! We are recruiting anEngineerfor a consulting engagement with our direct client a leading global biotechnology company.
Ideal Candidate: 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 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 within a lab.
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:
Preferred Skills:
Preferred Traits:
Top Must Have Skill Sets:
Day to Day Responsibilities:
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
Employee Value Proposition:Possibility of extension or conversion if FTE position comes available.
Interview Process:
Phone Screening
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.
Location:Cambridge MA 02138 OR Thousand Oaks Ca.
Business Unit:Physical Methods Development Modelling and Emerging Method
Employment Type: Contract
Duration:12 months with likely extensions or conversion to perm
Rate: 3842$/hours W2 with benefits
Posting Date:1/27/2025
Target Start Date:2/24/2025
3 Key Consulting is hiring! We are recruiting anEngineerfor a consulting engagement with our direct client a leading global biotechnology company.
Ideal Candidate: 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 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 within a lab.
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 company
- 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
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
Top Must Have Skill Sets:
- Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
- Mathematical background fundamentals of statistics
- Ability to manage multiple competing priorities simultaneously
Day to Day Responsibilities:
- Collaborate with Engineers using the system to edit develop and run automated experimental protocols.
- Run Gauge Repeatability and Reproducibility studies
- Assisting Engineers to successfully develop transfer and execute processes on the integrated platforms and equipment.
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
Employee Value Proposition:Possibility of extension or conversion if FTE position comes available.
Interview Process:
Phone Screening
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.
Regards
3KC Talent Acquisition Team
Required Experience:
Director
Employment Type
Full Time
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