Ideal Candidate BS/MS in Biomedical, Biologics, Mechanical, or related discipline, with laboratory experience in medidcal device design or research.
Title: Engineer Industry: Biotechnology, Medical Device, and Biopharmaceutical Contract Duration: 12 36 months (high possibility of extension or permanent conversion) Responsibilities: Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
Provide support of senior staff for investigations as well as new process development required to improve manufacturing operations.
Coordinate test method development and delivery with selected contractors and vendors.
Ensure that qualification parameters are met for product requirements.
Generate procedures necessary to support department and new process equipment.
Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals Participate in and assume responsibilities of team functions as assigned – i.e.
subject matter experts for test equipment Generate/author and own the Test Method documents: Procedures, engineering drawings, specifications, protocols, reports, etc.
Skills Required: BS or MS in Engineering-Mechanical, bio-logics, bio-medical, material sciences with focus on mechanical with laboratory experience or similar experience from school or work, someone that has worked on large projects, machine design, and technical writing exp.
Communication and team work experience Laboratory or similar experience (work/academic) Machine design Technical writing
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