Overview
Job Title : Engineer (JP12205C) Location : Cambridge, MA. OR Thousand Oaks, CA. 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.
Job Description
- 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.
Candidate Profile
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 studiesAssisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.Developing, enhancing, automating, and managing test dataNetwork with manufacturing and quality organizations internal to clientEnsuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPsMonitoring technological developments in the field & evaluation of new technologiesRequired Qualifications
3 YOE in field desired with bachelorsExperience working in a regulated industry.Exposure to GMPsMedical 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 leadershipAbility to manage multiple, competing priorities simultaneouslyStatistical 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 dataMaintain project status and communicate with client internal clientsBasic 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 GMPsExcellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadershipStatistical analysis, and knowledge of Gage R&R,Knowledge of Optical measurement devices, force testers, BLE testingTest method development, CAD design, Solidworks, mechanical modelingManufacturing experience, IQ, OQ, and PQPreferred Traits
Passion for proactively identifying opportunities through creative data analysis and modelingIntellectual curiosity with ability to learn new concepts / frameworks, algorithms, and technology rapidly as needs ariseAbility to manage multiple, competing priorities simultaneously, experience with MS ProjectWhy 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.
Application
We invite qualified candidates to send your resume to resumes@. If you decide that youre not interested in pursuing this particular position, please feel free to take a look at the other positions on our website . You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
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