Senior Validation Specialist

3 weeks ago

Swiftwater, United States Cynet Systems Full time
Job Description:

Pay Range $74.97hr - $78.97hr
  • Experience in authoring, reviewing, executing and approving validation documents.
  • Interface with Quality organization and the ability to defend rationale in validation documents.
  • bility to develop cleaning cycle and lead the investigation or trouble shooting.
  • bility to review and analyze data.
  • Cleaning Validation experience.
  • cceptance 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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