Validation Specialist III Framingham, PA 18370 Onsite 4 days a week most likely, 1 day remoteDuties
Experience in cleaning validation in the biologics or vaccine industry to include the following:
Experience in authoring, reviewing, executing and approving validation documents
Interface with Quality organization and the ability to defend rationale in validation documents
Ability to review and analyze data
Cleaning Validation experience
Acceptance criteria determination
Sampling procedures, plans and sample size determination
Rinse and Swab sampling experience
Bracketing and worse case rating
QC testing requirements
Dirty hold times and clean hold times
Basic Qualifications:
Experience utilizing Microsoft 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 4+ total years of experience working in a biologic, vaccine or pharma industry
