Title : Biomedical Technician III
Duration : 6+ Months
We are looking for a Sr R&D Lab Technician Disposables to work with our expert Cell and Gene Therapy Disposables Kit R&D team based in Marlborough, MA. Do you have a passion for cell therapy? Then we would love to hear from you.
What you'll do
Participate in the design and organization of experiments in conjunction with the Tech Lead and or R&D Team members. Serve as a resource to R&D Team.
Perform hands-on tests of new products in development. Prepare samples and execute tests, collaborating with colleagues as necessary to gain access and training. Record test data in accordance with GLP.
In addition to executing existing tests, you will also be expected to propose, design, improve, develop and/or implement new tests procedures for evaluating new product's specifications within the verification and validation activities framework.
Contribute to the generation of work instructions, tests protocols, and reports.
Follow departmental work instructions, SOP's, OSHA safety regulations and cGMPs & cGLPs to perform assigned tasks.
Monitor and oversee lab supply inventory, generate expense purchase requisitions, if applicable, and maintain documentation in accordance with established procedures.
Interface with internal groups to assure laboratory equipment maintenance, calibration and documents conform with established practices.
Who you are
Formal Training/ Education:
Minimum (required): Associates Degree in Technology or Engineering
Equivalent combination of education and work experience
Job-related Experience: Minimum (required):
? 8-10 years relevant work experience in medical device and/or life science industry (FDA 21CFR820, ISO13485)
Typical previous positions:
o Quality Control/Test Sr Lab Tech
o Sr R&D Product Development Tech
o Sr Manufacturing Engineering Tech (Production support, Mfg Process Development)
Knowledge, Skill or Ability:
Deep knowledge in medical device disposables (Class II), with relevant experience in developing tests methods, writing test protocols, and verifying product design specifications of new products.
Backgrounds in manufacturing process development related to medical device, disposables an asset (IQ, OQ, PQ, Process FMEA)
Basic knowledge of mechanical design of fixtures (CAD Design - SolidWorks)
Familiarity with the mechanical testing of plastic parts and sub-assemblies (e.g. tensile/shear/compression test, hardness measurement, pressure decay measurement, burst test) and product reliability tests (e.g. any tear/wear/aging test)
Ability to work under cGMP/cGLP guidelines
Strong communication, interpersonal skills and the ability to work in a team environment are required.
Demonstrate strong ethical behavior
Detail-oriented, and able to work independently as well as part of a team
Possess good computer skills (Microsoft Office is required. Word, Excel)
- provided by Dice