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LIMS Validation Consultant

Non-Headquarters

Valpro has several available opportunities supporting our world-class client sites or partner organizations.  Whether you are an independent consultant or a potential employee looking for your next project, learn more about what we have to offer. View our open positions below.

Job Title: LIMS Validation Consultant

Location: Sanford, NC

Note: Opportunity does not begin until May 2025, and it is short-term consulting.

Company: Valspec

About Valspec: Valspec specializes in compliance, validation, and consulting services for enterprise systems in regulated industries, including pharmaceuticals, biotechnology, and life sciences. We work closely with clients to ensure their systems meet regulatory standards, providing expertise in validation and implementation to support their operational goals.

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.

Benefits:

  • Competitive salary with performance-based bonuses
  • Remote work options with flexible scheduling
  • Comprehensive health, dental, and vision insurance
  • Professional development opportunities, including training and certifications
  • Collaborative and supportive work environment

How to Apply: Interested candidates should submit a resume and cover letter detailing relevant experience. Valspec is an equal-opportunity employer committed to building an inclusive work environment.

Valpro offers flexible career options that includes benefits such as paid time off, paid holidays, medical, 401K match, and other unique incentives.

Candidates must be legally eligible to work in the United States without company sponsorship.  Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valpro. Valpro will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valpro is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.

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