Job Description

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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