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Computer System Validation Consultant

Intellectt Inc
Saint Joseph, MO Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 6/2/2025

Job Title : Computer System Validation (CSV) Consultant

Location : St. Joseph, MO (Onsite)

Duration : 6-12 Months

Start Date : ASAP

Job Description :

We are seeking a Computer System Validation (CSV) Consultant to support lifecycle validation activities in a GMP manufacturing environment within the biological industry. The ideal candidate will have extensive experience in computerized systems validation , ERP systems, and regulatory compliance.

Key Responsibilities :

  • Perform lifecycle validation for computer-related systems in a GMP manufacturing environment.
  • Develop lifecycle documentation , execute validation protocols, and lead projects for computerized systems , including laboratory, computer, and LIMS systems .
  • Work with ERP systems such as SAP , QMS ( Veeva Vault ), and LIMS ( MODO, PV Works ).
  • Identify and address gaps in lifecycle documentation , ensuring compliance with industry regulations.
  • Support client site validation activities , ensuring all systems meet required standards.
  • Collaborate with cross-functional teams to achieve validation goals and regulatory requirements.

Qualifications & Experience :

  • 6 years of experience in computer-related systems validation within GMP industries.
  • Bachelor’s degree in Computer Science (preferred) or equivalent education / experience.
  • Strong knowledge of GMP regulations and computerized system compliance.
  • Hands-on experience with LIMS, ERP, and QMS systems .
  • Excellent documentation skills and attention to detail.
  • Ability to work on-site and support validation efforts effectively.
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