What are the responsibilities and job description for the Computer System Validation Consultant position at Intellectt Inc?
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.
