drjobs Validation Specialist Cleaning

Validation Specialist Cleaning

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1 Vacancy
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Job Location drjobs

Monroe County, PA - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Roles & Responsibilities:
  • BS/MS in Science (e.g. Chemistry Biochemistry Analytical Chemistry) or Engineering (Chemical or Biochemical) with 5 total years of experience working in a biologic vaccine or pharma industry.
  • 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.
  • 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.

Employment Type

Full Time

Company Industry

About Company

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