Validation Engineer
Core
Executing validation activities within a GMP manufacturing environment for inhaled powder spray drying and capsule manufacture, ensuring scientific soundness and regulatory compliance.
Role type
Validation Engineer (GMP Manufacturing)
Builds
Validated manufacturing processes, equipment, and systems for Dry Powder Inhaler (DPI) capsule manufacture and packaging.
Domain
Pharmaceutical manufacturing / GMP / Inhalation drug delivery
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, change control assessment, commissioning and qualification documentation review, deviation and CAPA management, SOP development, preventive maintenance planning, audit support, regulatory guideline knowledge (FDA/EMA/21 CFR)
Preferred skills
Process validation, cleaning validation, USP water systems, HVAC systems, critical utilities qualification, audit experience
Technologies
GEA Niro SD1/SD4/SD7, 21 CFR Part 210/211/11, EU Annex 15, GAMP, ASTM E2500, ICH, USP
Responsibilities
Execute validation activities including DQ, FAT, SAT, IQ, OQ, PQ, requalification, cleaning, sterilization, and process validation; Author, review, and approve validation and qualification documentation; Generate, review, and support deviations, CAPAs, and root cause investigations; Review and approve preventive maintenance and calibration plans; Serve as SME during internal and external audits and regulatory inspections.
Seniority
Mid-level, hands-on IC
