LIMS Validation Consultant

Job Description:

Position Summary:

As a LIMS Validation Consultant at Valspec, you will be responsible for planning, executing, and documenting the validation of Laboratory Information Management Systems (LIMS) to meet regulatory requirements. This role will focus on ensuring that LIMS platforms used in laboratory and research environments comply with relevant standards and regulatory guidelines, including GxP, 21 CFR Part 11, and ISO standards. You will collaborate closely with clients and project teams to ensure accurate validation and documentation of systems to support clients in achieving and maintaining regulatory compliance.

Key Responsibilities:

• Validation Planning and Strategy: Develop and implement validation plans, protocols, and strategies for LIMS platforms based on client requirements and industry regulations.
• Risk Assessment and Compliance Analysis: Conduct risk assessments and compliance gap analyses to identify critical aspects of the LIMS that require validation. Ensure compliance with regulatory standards, including FDA, GxP, and ISO requirements.
• Protocol Development and Execution: Create and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), to confirm system functionality, data integrity, and compliance.
• Documentation and Traceability: Prepare and maintain comprehensive documentation, including validation plans, test scripts, traceability matrices, risk assessments, and summary reports to support audit readiness.
• Testing and Verification: Conduct detailed testing and verification to validate the LIMS functionalities, security controls, and data handling processes, ensuring data integrity and compliance.
• Collaboration and Stakeholder Communication: Work with client stakeholders, including IT, quality assurance, and laboratory personnel, to coordinate validation activities, communicate findings, and resolve issues.
• Continuous Improvement: Identify opportunities to improve validation practices, streamline documentation processes, and enhance compliance standards in line with evolving regulatory requirements.
• User Training and Support: Provide training to end-users on validated systems, standard operating procedures, and best practices to ensure sustained compliance.

Qualifications:

• Education: Bachelor’s degree in a relevant field (e.g., Life Sciences, Computer Science, Engineering, or related discipline); advanced degrees or relevant certifications (e.g., ASQ Certified Quality Auditor, Certified Quality Engineer) are a plus.
• Experience: 3+ years of experience in validating Laboratory Information Management Systems (LIMS), ideally within regulated industries such as pharmaceuticals, biotechnology, or life sciences.
• Technical Skills:
  • Proficiency with common LIMS platforms (e.g., LabWare, STARLIMS, LabVantage) and experience with validation in laboratory environments.
  • Strong understanding of regulatory standards (FDA 21 CFR Part 11, GxP, ISO 17025, etc.) and quality management systems.
  • Familiarity with automated testing tools and methodologies for validation.
• Soft Skills:
  • Excellent documentation and technical writing skills.
  • Strong attention to detail and analytical thinking.
  • Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams and clients.
  • Ability to manage multiple projects and prioritize tasks effectively.