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Katalyst Healthcares & Life Sciences
Bothell, WA | Full Time
$87k-107k (estimate)
3 Weeks Ago
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Validation specialist
$87k-107k (estimate)
Full Time 3 Weeks Ago
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Katalyst Healthcares & Life Sciences is Hiring a Validation specialist Near Bothell, WA

RESPONSIBILITIES :

Strong knowledge of GAMP / risk-based approaches to validation (i.e., Computer Software Assurance CSA ), and good understanding of electronic record / signature management practices.

Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews / Periodic review), coordinating with business owners, technical system owners and Quality in accordance with company procedures and regulatory requirements.

Author, review and / or approve applicable CSV documentation.

Perform or oversee test script execution efforts, including defect management.

Ensure validation test strategies align with internal procedures and requirements for intended use.

Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.

Experience in following CSV methodology for system evaluations, changes, and implementations.

Ability to work independently.

Requirements :

  • Education : Master's Degree with 2 years of direct experience in Validation in pharmaceutical, biotechnology.
  • Related industry, preferably in FDA-regulated environments.
  • Bachelor's Degree with 4 years of direct experience in Validation.
  • Pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
  • Experience in a biotechnology or pharmaceutical cGMP manufacturing environment preferred.
  • Experience with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts IQ / OQ / PQ , Reports, Trace Matrices, SOPs, etc.).
  • 3-5 years' experience in performing periodic review of computerized systems.
  • Experience with Val genesis / Veeva Vault CR / PR / CAPA systems.
  • Strong critical thinking and problem-solving skills.
  • Strong interpersonal skills to work with teams in different functions and organizations GXP Equipment Validation.
  • Last updated : 2024-06-13

Job Summary

JOB TYPE

Full Time

SALARY

$87k-107k (estimate)

POST DATE

05/22/2024

EXPIRATION DATE

06/14/2024

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.