Senior Facility Manager
systems (CMMS) Understanding of cGMP engineering requirements including qualification protocols (IQ/OQ/PQ) Location: Based...
systems (CMMS) Understanding of cGMP engineering requirements including qualification protocols (IQ/OQ/PQ) Location: Based...
Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis Work...
, highly controlled manufacturing, or validation-heavy industries. Familiarity with IQ/OQ/PQ and CFR-style methodologies...
for equipment, processes, and related systems. Develop and execute validation protocols (IQ/OQ/PQ) for equipment, sanitation... and execution of IQ, OQ, and PQ protocols. Strong knowledge of process validation principles and practices. Demonstrated ability...
and contributes to long range investment plan Reviews and approves design packages, validation documents (IQ/OQ/PQ), purchase orders...
. Generate/evaluate qualification/validation protocols including IQ, OQ, FT, PQ protocols and final reports for new or modified... GMP analytical and process equipment, utilities, and facilities. Execute IQ, OQ, FT, PQ protocols, which may involve...
and qualification activities including IQ, OQ, PQ execution, protocol support, deviation investigations, and change control activities.... Experience participating in IQ/OQ/PQ activities, equipment commissioning, validation, and change control processes. Experience...
(FRA), test scenario and test case design, SIT/UAT/OQ/PQ execution, defect management, traceability management, test evidence...
, ensuring minimal disruption to manufacturing schedules. Lead and support process validation activities (IQ, OQ, PQ) for new... Qualification (OQ), and Performance Qualification (PQ). Experience conducting non-conformance investigations, including root cause...
protocols including IQ, OQ, and PQ. Ensure systems remain in a validated state throughout their lifecycle. Author and maintain...