Validation Engineer

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 by communication with impacted departments and personnel. The Validation Engineer will author validation documents and execute validations of equipment and production processes, as well as oversee contractors or equipment vendor technicians during contracted validation/qualification activities.

MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)

• Interface effectively with personnel in IT, Operations, Quality, Supply Chain, Manufacturing and other technical disciplines.
• Author qualification plans, impact assessments, validation protocols, risk assessments, validation reports, and other documents supporting validation for new and existing manufacturing equipment and processes.
• Perform and manage qualification testing 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 (1 years’ for Associate or 4 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.