USA-Validation Specialist III (Engineering)
Website TalentBurst, Inc.
Company : TalentBurst, Inc.
Country: United States
Location : Swiftwater, Pennsylvania
Post: Sun, 02 Oct 2022 03:28:16 GMT
Expires: Sun, 30 Oct 2022 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
Position: Validation Specialist
Location: Swiftwater, PA
Duration: 5 months
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
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
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.
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.
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