and deviation investigations Ability to support IQ/OQ/PQ activities, Environmental monitoring requirements, Internal and external...
. Significant background in engineering testing and analysis including: Direct experience of test equipment validation (IQ, OQ, PQ...
, and execute IQ/OQ/PQ protocols for manufacturing equipment, utilities, and cleanroom systems. Lead process validation activities... in a cGMP-regulated manufacturing environment. Hands-on experience authoring and executing IQ/OQ/PQ validation protocols...
with process validation (IQ, OQ, PQ) and control plan development Lean / Six Sigma experience or certification Experience...
(IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis Work with suppliers to execute cost reductions...
and resolve issues Lead/support product transfer to manufacturing Execute process validation (IQ/OQ/PQ) Improve manufacturing...
Qualification (PPQP) deliverables, including Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R...
, and connector standards Proficiency in Lean/Six Sigma, SPC, capability analysis, manufacturing validation processes (IQ, OQ, PQ..., Optical Testing, DOE, Six Sigma, SPC, Process Development, Manufacturing Validation, IQ OQ PQ, Lean Manufacturing, Lakeville...
(SOPs), batch records, and validation protocols. Plan, execute, and oversee process validation studies (IQ/OQ/PQ...
and document in qualification plans. 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...