QCS Staffing · 2 weeks ago
DTI Validation Lead
North Carolina, United States
Full-time
Onsite
Senior LevelQCS Staffing is seeking a DTI Validation Lead for a globally recognized pioneer in Biotechnology. The role involves developing validation strategies for digital technology systems and ensuring compliance and data integrity standards are met during the construction of a new biomanufacturing plant.
ConsultingProfessional ServicesRecruitingStaffing Agency
Responsibilities
Develop and own the validation strategy for digital technology systems (e.g., MES, DCS/SCADA, Historian, lab systems, asset management tools, and digital workflow platforms)
Lead CSV (Computer System Validation) planning and execution
Collaborate with engineering, automation, IT, quality, and construction teams to ensure integration and data flow meet compliance and data integrity standards
Ensure validation deliverables (URS, FS/DS, IQ/OQ/PQ, risk assessments, etc.) are created, reviewed, and approved per project timelines
Qualification
Required
Extensive experience in CSV/automation/IT validation within pharmaceutical or biotech manufacturing
Strong knowledge of GAMP 5, Data Integrity principles (ALCOA), and GMP regulations
Proven leadership in cross-functional environments and vendor/contractor management
Preferred
Experience supporting greenfield/brownfield CAPEX projects highly preferred
Company
QCS Staffing
Formerly Quanta.
Founded in 1989
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase