What are the responsibilities and job description for the Computer Systems Validation Lead position at LABUR?
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Overview
LABUR is partnering with a client to address a critical compliance challenge within their ERP environment. We are supporting an initiative to ensure that the ERP system meets stringent regulatory requirements, including FDA 21 CFR Part 11, GAMP 5, and other applicable standards. This engagement requires a seasoned Computer Systems Validation (CSV) Lead who can provide strategic oversight and hands-on expertise across validation planning, leadership, protocol development, execution, and documentation. The resource will play a pivotal role in safeguarding GxP systems and enabling the client to maintain operational integrity while meeting regulatory expectations.
Responsibilities
$80 - $90 per hour - Dependent on fit and experience.
Overview
LABUR is partnering with a client to address a critical compliance challenge within their ERP environment. We are supporting an initiative to ensure that the ERP system meets stringent regulatory requirements, including FDA 21 CFR Part 11, GAMP 5, and other applicable standards. This engagement requires a seasoned Computer Systems Validation (CSV) Lead who can provide strategic oversight and hands-on expertise across validation planning, leadership, protocol development, execution, and documentation. The resource will play a pivotal role in safeguarding GxP systems and enabling the client to maintain operational integrity while meeting regulatory expectations.
Responsibilities
- Develop, lead, and execute validation deliverables including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), IQ/OQ/PQ protocols, and Validation Summary Reports.
- Lead or support validation efforts for ERP systems, including instrument interface assessments.
- Ensure systems meet compliance requirements (e.g., 21 CFR Part 11, EU Annex 11) and align with GMP/GLP practices.
- Conduct risk assessments, gap analyses, and periodic reviews for validated systems.
- Collaborate with cross-functional teams to support system lifecycle activities.
- Maintain and manage validation documentation, SOPs, and change control records.
- Provide technical support and training to system users and stakeholders.
- Participate in internal audits and support regulatory inspections as needed.
- Bachelor’s degree in Computer Science, Life Sciences, Engineering, or related field.
- Minimum 5–7 years of experience in CSV within regulated industries (pharma, biotech, medical devices).
- Proven expertise in validating ERP systems (ex. Oracle, SAP, etc.).
- Strong understanding of GAMP 5, 21 CFR Part 11, ISO, and SOX compliance frameworks.
- Experience with SDLC methodologies and documentation suites.
- Familiarity with related systems such as TrackWise, Veeva Vault, SAP, or MES is a plus.
- Excellent communication, documentation, presentation, and project management skills.
- Ability to effectively face off with high level stakeholders.
- Excellent attention to detail.
$80 - $90 per hour - Dependent on fit and experience.
Salary : $80 - $90