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Associate Validation Engineer/Validation Engineer

2 months ago

Cleveland, United States Abeona Full time

POSITION PROFILE: Abeona is seeking an Associate Validation Engineer (1+ years’ industry experience) or Validation Engineer (4+ years’ industry validation experience) to support validation activities. This person must have GMP experience writing, reviewing, and/or documenting in a regulated industry, preferably biotech, pharmaceutical or medical device . The Engineer will coordinate validation activities

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t es ti n g including leading multifunctional project specific meetings Responsible for overseeing technicians/contractors and providing necessary guidance. Responsible for the generation of protocols using a risk-based approach that meets current regulatory requirements and industry practices. Responsible for managing to individual and team goals Organize project binders and file department reports as needed Update a computer-based asset tracking system with validation status Performs other duties as assigned QUALIFICATIONS (Education/Training, Experience and Certifications) BS degree in Engineering or Life Science (Chemistry, Bio, Physics, etc.) Relevant industry experience (

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+ years’ for Engineer) preferably in Biotech, Pharmaceutical or Medical Device. KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently) Strong communication skills, both verbal and written; ability to work and interface with all levels of the organization. Ability to work independently and as a team member, as well as, with Consultants/Contractors to achieve projects' validation objectives. Strong analytical and problem-solving abilities Strong computer skills, specifically being proficient in Microsoft Word, Excel, and Outlook Ability to manage multiple concurrent tasks/studies.

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