Senior Validation Engineer
Core
Lead planning, scheduling, and execution of validation projects (qualification, validation, requalification) for manufacturing processes, equipment, utility systems, products, cleaning, and sterilization in a cGMP environment.
Role type
Senior IC validation engineer (pharmaceutical manufacturing)
Builds
Validated manufacturing processes, equipment, and systems for pharmaceutical/biotech clients
Domain
Pharmaceutical manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP validation lifecycle management, regulatory compliance (FDA/EMA/ISO/NRC), validation documentation authoring (URS/FRS/DQ/IQ/OQ/PQ/FAT/SAT), root cause analysis, project management, risk assessment, statistical analysis
Preferred skills
Equipment/process/cleaning/utility/CSV validation, nuclear pharmaceutical manufacturing regulations, gap analysis, continuous improvement
Technologies
Validation protocols, SOPs, statistical analysis tools
Responsibilities
Lead validation projects from start to finish; author and review comprehensive validation documentation; ensure compliance with cGMP and regulatory agencies; support troubleshooting and root cause investigations; manage cross-functional collaboration; drive continuous improvement in validation programs; support regulatory inspections and audits.
Seniority
Senior, hands-on IC
