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.
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.
ATS Match is available
1) Upload your resume. 2) Open any job and click Check ATS Match to see your fit score.
Sign in to check your resume match