Technology Lead –Labs Analytical Instrument Qualification (AIQ)

Job Title: Labs Analytical Instrument Qualification (AIQ) Technology Lead

Location: Wilson, NC

• Lead the delivery of Technology components of laboratory capital projects, providing technical, financial, and strategic oversight from concept through implementation
• Own systems analysis and solution design for GxP-regulated laboratory systems, ensuring compliance with regulatory, data integrity, and cybersecurity requirements
• Lead and manage engagement with third-party vendors for the provision of laboratory software solutions, ensuring technical fit, regulatory compliance, and value for money
• Act as a technical and financial authority for laboratory Technology platforms, setting standards, design principles, and investment priorities aligned with enterprise architecture
• Develop and manage capital and operational budgets for laboratory Technology initiatives, ensuring accurate cost estimation, financial control, and value realization
• Drive long-term technology and investment forecasting for laboratory systems, aligning roadmaps with business strategy, lifecycle planning, and obsolescence management
• Provide senior-level, on-demand technical and financial advice to business, quality, and engineering stakeholders, presenting clear, risk-based options and recommendations
• Partner with Finance, Procurement, and Project teams to support business cases, funding approvals, and vendor cost models
• Ensure alignment between IT, Quality, Engineering, Validation, and external vendors to deliver compliant, cost-effective solutions
• Partner with IT Infrastructure and Network team to provide IT requirements and collaborate to configure the Labs Instruments to the IT ecosystem
• Ensure Cyber Security Standards are followed as per company standards and policies
• Support the planning and execution of IOPQ protocols, providing technical input, system configuration support, and issue resolution during qualification activities
• Review and approve system designs, change impacts, risk assessments, and qualification readiness for regulated environments
• Represent the Labs in audits, inspections, and regulatory interactions, confidently defending system architecture, controls, and qualification outcomes
• Mentor and guide junior engineers and project team members, building technical capability, validation awareness, and design consistency

• Strong understanding of Windows operating systems at both workstation and server levels
• Solid knowledge of networking concepts, including firewall configurations
• Working knowledge of cybersecurity fundamentals and secure system design
• Good understanding of 21 CFR Part 11 requirements and data integrity guidelines in regulated environments
• Strong troubleshooting skills combined with clear communication, escalation management, and decision-making
• Good understanding of client-server architecture and client-server-based solutions used in laboratory environments
• Experience with the implementation of laboratory technologies such as TOC, Endotoxin, UV, and SoloVPE systems would be advantageous

• Strong interpersonal skills with the ability to relate well to others
• Excellent oral and written communication skills, with proven ability to communicate and build relationships cross-functionally
• Confident in presenting technical information in audit and inspection settings
• Able to translate technical concepts into clear, stakeholder-friendly language