Labvantage LIMS Validation Specialist / Senior Validation Engineer 2
A leading life sciences consultancy is seeking a skilled LabVantage LIMS Validation Specialist to support a major project within a regulated laboratory environment. This role involves overseeing the full validation lifecycle of LabVantage LIMS, ensuring compliance with GxP standards and regulatory requirements. The successful candidate will bring hands-on experience in system configuration, documentation, and validation, with familiarity in tools like ValGenesis considered a strong asset.
Key Responsibilities:
- Lead validation efforts for LabVantage LIMS, including planning, documentation, and execution within a GxP-compliant setting.
- Create and maintain Computer System Validation (CSV) deliverables such as Design Specifications, User Requirements, and Functional Requirements.
- Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Collaborate with cross-functional teams including IT, QA, and laboratory staff to ensure seamless implementation.
- Configure and test the LIMS system, troubleshoot issues, and ensure alignment with business and regulatory needs.
- Author and revise Standard Operating Procedures (SOPs) and validate spreadsheets used in lab operations.
- Utilize validation lifecycle management tools (e.g., ValGenesis) to streamline documentation and ensure audit readiness.
- Provide training and support to end users to facilitate system adoption and compliance.
Qualifications:
- Minimum of 5 years' experience in validating LabVantage LIMS within a GxP-regulated environment.
- Proficient in authoring CSV documentation and managing lab system qualifications.
- Familiarity with validation management platforms such as ValGenesis.
- Strong understanding of regulatory frameworks including 21 CFR Part 11 and data integrity principles.
- Demonstrated ability to work independently and lead complex validation projects.
- Excellent problem-solving, communication, and collaboration skills.
Additional Information:
- Preference for candidates able to work on-site in Somerset, NJ, though remote arrangements may be considered.
- Project start is immediate, with engagement expected through the end of 2025 and potential extension into early 2026.
Work Culture & Values:
- Commitment to professional growth and continuous learning.
- Focus on collaboration, integrity, and client success.
- Inclusive and respectful workplace that values diverse perspectives.
- Supportive team environment with opportunities to make a meaningful impact.
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