Job Information
Abeona Associate Validation Engineer/Validation Engineer in Cleveland, Ohio
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 co m m un i c at i on wi t h impacted d e p ar t m en t s and p er s onn e l . T he V a l i d a ti o n Engineer will a u t h o r v a li d a t i o n docu m en t s a nd e x ec u t e v a l id a t i o n s of eq u i p m ent 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)
I n t erface e f fe c ti v e l y w i t h pers o nn e l i n I T , Operations , Q ua l it y , Supply Chain, Manufacturing and o t her t e chn i c a l d i s c i p li n es.
A u t hor qualification pl a ns, impact assessments, v a l i d a ti o n pr o t o co l s, r i sk asse s s m en t s, v a li d a t i on rep o r t s, and o t her docu m en t s sup p or t i ng v a l i d a ti on f o r new a n d ex i s t i ng m anufa c t u r i ng eq u i p m en t and pr o c e s ses.
P erf o r m and m ana g e qualification 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 ( 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.
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