, Physics, or Mechanical Engineering Technology Preferred Qualification “PQ” – Bachelor’s Degree in Mechanical, Manufacturing...
Method Validation (TMV) for inspection and functional test methods, including IQ/OQ/PQ where required, with documented...
/PQ and manufacturing process controls. Understanding of SPC, pFMEA, risk management, root cause analysis...
sites, ensuring IQ/OQ/PQ, equipment qualification, data integrity, and regulatory expectations are met. Serve as the... that meet contract, QA, and regulatory standards (validation protocols, IQ/OQ/PQ records, SOP alignment, QA approvals...
Change Management processes. Understanding of validation principles including IQ/OQ/PQ methodologies. Strong technical...
sites, ensuring IQ/OQ/PQ, equipment qualification, data integrity, and regulatory expectations are met. Serve as the... that meet contract, QA, and regulatory standards (validation protocols, IQ/OQ/PQ records, SOP alignment, QA approvals...
to Engineering and Manufacturing Perform engineering testing supporting: Design Verification Process Validation (IQ/OQ/PQ...
processes. Oversee equipment qualification (IQ/OQ/PQ) and capacity planning for new production lines, cleanroom expansions...
sourcing and installation of new equipment including IQ/OQ/PQ’s. Construct of work centers that enable proper and efficient...
with FDA, EMA, and GxP guidelines. Develop and execute validation protocols including IQ, OQ, and PQ. Ensure systems remain... requirements gathering and documentation. Author and execute validation test cases. Perform IQ/OQ/PQ, UAT, and end-to-end testing...