Sr. Process Engineer
(PQ) protocols, risk assessments, Standard Operating Procedures (SOPs), and Manufacturing Batch Records for developmental...
(PQ) protocols, risk assessments, Standard Operating Procedures (SOPs), and Manufacturing Batch Records for developmental...
-on, technical role where you'll lead IQ/OQ/PQ activities, drive process improvements, and act as the go-to expert for manufacturing... with experience in regulated environments (medical device preferred) Strong background in process validation (IQ/OQ/PQ) Knowledge...
required;target experience range of 2-4 years +. Validation experience (IQ/OQ/PQ) strongly preferred. Interview & Location...
and process qualification activities (IQ/OQ/PQ) in collaboration with internal manufacturing teams and CMOs. Provide technical...
(functional test, bed-of-nails, HIL systems) for complex PCBAs Perform validation (IQ, OQ, PQ) of test hardware, test software...
& Process Oversight: Provide quality oversight for IQ/OQ/PQ qualification activities. Review and approve protocols, reports...
, OQ, and PQ protocols in compliance with GMP and regulatory requirements. Assist with startup, troubleshooting, testing... within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments. Working knowledge of IQ/OQ/PQ...
. Support equipment qualification (IQ/OQ/PQ) and lifecycle management. Provide calibration input into risk assessments, URS...
specification, procurement, and IQ/OQ/PQ Participation with internal and CM resources to assess the HSE and PSM elements of the CM...
and compliance strategy across IQ/OQ/PQ activities, maintaining the highest levels of regulatory integrity across the LP1 digital...