Principal QA Validation Specialist, Fill Finish

Discover Your Role Lead validation and serve as SME for utilities and environmental qualification; assess change controls, review CAPAs/NOEs, approve documents, and lead audits Plan and execute cleanroom qualifications and requalification; oversee EMPQ for filling line clean air equipment Drive QRM deliverables including HACCP assessments and continuous trending/reporting Lead investigations of contamination events linked to environmental monitoring in cleanrooms and clean air equipment Qualify critical utilities: Water for Injection (WFI), pharmaceutical air, AHUs, clean steam generators, and nitrogen distribution systems Manage/develop a specialist and consultants to meet milestones and deliver qualification/documentation Establish processes ensuring regulatory compliance, including participation in Annex 1 gap assessments Influence creation/revision of local/global policies, standards, procedures, and business processes Demonstrated experience in a cGMP-regulated environment with validation, inspection, and audit readiness Strong cross-functional collaboration and communication skills This Role Requires BS/BA in Engineering, Chemistry, or Life Sciences and 8+ years of relevant experience Experience in utility and facility qualification/validation The Environment And Physical Rhythms Of The Role Full cleanroom attire; remove jewelry/makeup/nail adornments when wearing cleanroom attire #J-18808-Ljbffr Scorpion Therapeutics