USA-Validation Specialist III

2 weeks ago

Swiftwater, United States Hire Talent Full time

Job Title: Validation Specialist

Job Location: Swiftwater,PA

Job Duration: 12 months on W2

Duties

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 develop cleaning cycle and lead the investigation or trouble shooting. Ability to review and analyze data. Cleaning Validation experience Acceptance criteria determination Sampling 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 2+ total years of experience working in a biologic, vaccine or pharma industry

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