, cleaning, and calibration verification of SMT equipment. Support process engineers in equipment qualification (IQ/OQ/PQ...
Validation (CSV) activities, including documentation and execution (URS, IQ/OQ/PQ, RTM). Overseeing User Acceptance Testing (UAT...
for Approval SOPs and Manufacturing Procedures Develops and Executes Component Qualifications Develops and Executes PQ and PPQ... Transfers Product / Process Development Job Functions Experience in the following: Qualification / Validation (IQ/OQ/PQ...
Level Risk Assessments), DI (Data Integrity) Assessments, DR/DQ, Specifications, IQ/OQ/PQ Qualification Protocols/Issues...
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...
and resolve issues Lead/support product transfer to manufacturing Execute process validation (IQ/OQ/PQ) Improve manufacturing...
(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...