Labs Analytical Instrument Qualification (AIQ) Technology Lead

Labs Analytical Instrument Qualification (AIQ) Technology Lead Location: Wilson, NCWe are hiring a Labs Analytical Instrument Qualification (AIQ) Technology 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 ResponsibilitiesLead the delivery of Technology components of laboratory capital projects, providing technical, financial, and strategic oversight from concept through implementationOwn systems analysis and solution design for GxP‑regulated laboratory systems, ensuring compliance with regulatory, data integrity, and cybersecurity requirementsLead 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 architectureDevelop and manage capital and operational budgets for laboratory Technology initiatives, ensuring accurate cost estimation, financial control, and value realizationDrive long‑term technology and investment forecasting for laboratory systems, aligning roadmaps with business strategy, lifecycle planning, and obsolescence managementProvide senior‑level, on‑demand technical and financial advice to business, quality, and engineering stakeholders, presenting clear, risk‑based options and recommendationsPartner with Finance, Procurement, and Project teams to support business cases, funding approvals, and vendor cost modelsEnsure alignment between IT, Quality, Engineering, Validation, and external vendors to deliver compliant, cost‑effective solutionsPartner 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 or followed as per company standards and policiesSupport the planning and execution of IOPQ protocols, providing technical input, system configuration support, and issue resolution during qualification activitiesReview and approve system designs, change impacts, risk assessments, and qualification readiness for regulated environmentsRepresent the Labs in audits, inspections, and regulatory interactions, confidently defending system architecture, controls, and qualification outcomesMentor and guide junior engineers and project team members, building technical capability, validation awareness, and design consistencyTechnical SkillsStrong understanding of Windows operating systems at both workstation and server levelsSolid knowledge of networking concepts, including firewall configurationsWorking knowledge of cybersecurity fundamentals and secure system designGood understanding of 21 CFR Part 11 requirements and data integrity guidelines in regulated environmentsStrong troubleshooting skills combined with clear communication, escalation management, and decision‑makingGood understanding of client‑server architecture and client‑server-based solutions used in laboratory environmentsExperience with the implementation of laboratory technologies such as TOC, Endotoxin, UV, and SoloVPE systems would be advantageous.Soft SkillsStrong interpersonal skills with the ability to relate well to othersExcellent oral and written communication skills, with proven ability to communicate and build relationships cross‑functionallyConfident in presenting technical information in audit and inspection settingsAble to translate technical concepts into clear, stakeholder‑friendly language