Lab Systems Architect

BCTG's direct client is looking for a Lab Systems Architect Lead for a greenfield manufacturing site implementation project. This role will report into the Quality Control Laboratories organization and will partner closely with QC, IT, Engineering, and vendors to ensure compliant and on?time instrument qualification., * Lead the end-to-end AIQ lifecycle across a diverse instrument portfolio, including IQ, OQ, and PQ activities

• Establish and manage the instrument inventory, qualification tracking, SOPs, templates, and documentation framework
• Author, review, and approve qualification protocols and reports in alignment with USP <1058>, 21 CFR Part 11, and Annex 11
• Serve as the technical lead for laboratory systems, ensuring compliant solution design, data integrity, and cybersecurity alignment
• Partner with QC, IT, Engineering, QA, and vendors to coordinate qualification activities and deliver on schedule
• Lead vendor engagement for lab systems and instrument integration, ensuring technical fit and regulatory compliance
• Support execution of IOPQ, risk assessments, and validation readiness for regulated environments
• Act as a primary contact for audits and inspections, defending qualification strategy and system controls
• Provide oversight on lab technology investments, including budgeting, forecasting, and lifecycle planning
• Mentor junior team members and drive best practices across validation and lab operations

• 7+ years of AIQ experience within GxP pharmaceutical or life sciences environments
• Strong knowledge of USP <1058>, 21 CFR Part 11, Annex 11, and global regulatory expectations
• Hands-on experience qualifying a wide range of lab instruments (HPLC, UV/Vis, dissolution, KF, FTIR, endotoxin, balances, etc.)
• Experience with lab systems such as LIMS, SDMS, and CDS (e.g., LabVantage, NuGenesis, Empower) and instrument integration
• Strong understanding of data integrity, client-server architecture, and lab IT environments
• Experience in greenfield or large-scale lab implementations preferred

Additional Strengths

• Strong communication and stakeholder management skills across business, IT, and quality teams
• Ability to manage multiple workstreams and drive execution in a fast-paced environment
• Comfortable operating in audit-facing roles and presenting to senior stakeholders