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Katalyst Healthcares & Life Sciences
Swiftwater, PA | Contractor
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Validation Specialist
$52k-69k (estimate)
Contractor 0 Months Ago
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Katalyst Healthcares & Life Sciences is Hiring a Validation Specialist Near Swiftwater, PA

Responsibilities :
  • 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
Requirements:
  • 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 7 total years of experience working in a biologic, vaccine, or pharma industry. Cleaning and eventually shipping studies. Following gMP guidelines. Engineering degree. Cleaning validation (CV) great. NOT computer validation.

Job Summary

JOB TYPE

Contractor

SALARY

$52k-69k (estimate)

POST DATE

04/01/2023

EXPIRATION DATE

05/18/2024

WEBSITE

katalysthls.com

HEADQUARTERS

South Plainfield, NJ

SIZE

<25

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The following is the career advancement route for Validation Specialist positions, which can be used as a reference in future career path planning. As a Validation Specialist, it can be promoted into senior positions as a Validation Engineer II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Validation Specialist. You can explore the career advancement for a Validation Specialist below and select your interested title to get hiring information.