USA-Validation Specialist III

THIS IS A CLEANING VALIDATION POSITION.

Duties

" Experience in cleaning validation in the biologics or vaccine industry to include the following:
o Experience in authoring, reviewing, executing and approving validation documents.
o Interface with Quality organization and the ability to defend rationale in validation documents.
o Ability to develop cleaning cycle and lead the investigation or trouble shooting.
o Ability to review and analyze data.
" Cleaning Validation experience
o Acceptance criteria determination
o Sampling plans and sample size determination
o Rinse and Swab sampling experience
o Bracketing and worse case rating
o QC testing requirements
o Dirty hold times and clean hold times
Basic Qualifications:
" Experience utilizing Client Word, Excel, and Outlook
" Experience writing and revising documents (e.g. testing methods, protocols, reports)
" Experience performing testing in a GMP setting
" MS Project experience
Skills
" Proficiency in utilizing documentation system to author protocols and reports
" Experience participating in teams and collaborative work environments.
" Good communication skills (verbal and written), math skills, general computer skills
" Team environment a must
" E Doc/GEODE+ experience with a working knowledge of templates, workflows and approval process
" Strong root cause analysis with cGMP experience.

Education

" BS/MS in Science (e.g. Chemistry, Biochemistry, Analytical Chemistry) or Engineering (Chemical or Biochemical) with 2+ total years of experience working in a biologic, vaccine or pharma industry