Manufacturing Engineer II - JDAS
Qualifications, Operational Qualifications and PQ and process qualifications. Aid the production floor to evaluate and resolve...
Qualifications, Operational Qualifications and PQ and process qualifications. Aid the production floor to evaluate and resolve...
, and reduce costs Perform equipment and process validation (IQ/OQ/PQ) to ensure equipment meets specifications, performance...
development through SAT/IQ/OQ/PQ. Ensure that the procedures and systems are in place to facilitate the introduction of new...
. Mandatory IOQ experience with Filter Press or Centrifuge (one required). Hands-on execution of IQ, OQ, PQ for capital projects...
assessment, protocols (DQ, IQ, OQ, PQ) summary reports, and validation master plans/reports. As member of global engineering...
and PQ) Participate in teams chartered with commercializing new pharmaceutical products incl. non-sterile, sterile...
with regulatory and internal requirements. Execute and support process validation activities including IQ, OQ, and PQ. Lead... validation activities (IQ, OQ, PQ). Strong documentation, verbal, and written communication skills....
(OQ), and Performance Qualification (PQ) testing. Ensure equipment and systems meet design specifications, user.... Strong understanding of IQ/OQ/PQ processes, GMP regulations, and industry standards (ISPE Baseline Guides, ASTM E2500). Ability to read...
requirement Experience writing and executing validation protocols, including IQ/OQ/PQ documentation Expertise in risk assessment...
. Responsible to support facilities, utilities, and equipment IQ/OQ/PQ or any other validation activity as required. Ensure...