Life Science (LIMS/CSV) Testing Consultant

LIMS & CSV Solution Leadership
- Lead end-to-end implementation, enhancement, and support of LIMS solutions for pharma/biotech clients.
- Define and execute Computer System Validation (CSV) strategies, including validation plans, test strategies, and traceability matrices.
- Ensure all LIMS and related systems are implemented in alignment with GxP, 21 CFR Part 11, Annex 11, and relevant regulatory expectations.
- Conduct impact assessments and risk-based validation for system changes, upgrades, and new deployments.
2. Requirements, Design & Stakeholder Management
- Engage with business stakeholders to gather, analyze, and document requirements for laboratory and quality processes.
- Translate business needs into functional and technical specifications for LIMS and associated systems.
- Facilitate workshops, walkthroughs, and design sessions with cross-functional teams and client SMEs.
- Act as primary point of contact for client stakeholders, managing expectations, scope, and priorities.
3. Project & Delivery Management
- Plan, track, and manage LIMS/CSV project activities, timelines, and deliverables in line with project management best practices.
- Coordinate with internal teams, vendors, and client IT/QA teams to ensure smooth execution and on-time delivery.
- Identify project risks and issues, propose mitigation plans, and drive resolution.
- Ensure high-quality documentation and adherence to SDLC and validation lifecycle processes.
4. Compliance, Quality & Governance
- Establish and maintain validation documentation (URS, FS, DS, IQ/OQ/PQ, SOPs, work instructions).
- Support internal and external audits, inspections, and regulatory reviews related to LIMS and computerized systems.
- Promote and enforce compliance with GxP, data integrity, and quality standards across project teams.
- Drive continuous improvement in validation and compliance practices, templates, and methodologies.
5. Leadership, Mentoring & Best Practices
- Mentor and guide junior consultants and team members in LIMS, CSV, and GxP practices.
- Contribute to building internal accelerators, frameworks, and reusable assets for LIMS and CSV projects.
- Champion knowledge sharing, training sessions, and communities of practice within the organization.
- Provide thought leadership on emerging trends in lab informatics, validation, and regulatory expectations.

Graduation in Life Sciences, Pharmacy, Biotechnology, Chemistry, Computer Science, Engineering, or a related discipline.
- 9-18 years of total experience, with substantial hands-on exposure to LIMS implementations in regulated environments.
- Strong, demonstrable experience in Computer System Validation (CSV) across the full validation lifecycle.
- Proven experience working in GxP-compliant environments (e.g., GMP, GLP, GCP) with clear understanding of data integrity principles.
- Ability to create and review key validation deliverables (URS, FS, DS, IQ/OQ/PQ, test scripts, traceability matrices).
- Experience collaborating with business, QA, and IT stakeholders on system design, testing, and deployment.
- Solid communication skills, with the ability to explain complex regulatory and technical concepts to non-technical stakeholders.

You will play a pivotal role in shaping and delivering high-impact LIMS and CSV solutions for global life sciences and pharmaceutical clients. Leveraging your deep expertise in GxP environments, you will guide customers through their digital quality and laboratory transformation journeys, ensuring systems are compliant, efficient, and future-ready. In this role, you will collaborate closely with cross-functional teams-business stakeholders, QA, IT, and vendors-to design robust solutions that align with regulatory expectations and business goals.
As a senior member of the team, you will mentor consultants, drive best practices, and bring structure and clarity to complex projects. You will have the opportunity to influence strategy, standardize methodologies, and contribute to reusable frameworks and accelerators. If you enjoy solving complex problems, leading from the front, and creating tangible value in regulated environments, this role offers a platform to make a meaningful impact while working in a collaborative, supportive culture.