expectations. Support commissioning, qualification, and validation (IQ/OQ/PQ‑aligned testing methodology) of robotic systems...
safety perspective. Support contract manufacturing in performing equipment IQ, OQ, and PQ. Maintain and update packaging... to provide technical solutions. Proficiency in SolidWorks to create packaging concepts and drawings. Experienced with IQ/OQ/PQ...
and quality requirements. Lead supplier validation activities (IQ, OQ, PQ), support initial builds and commercialization of new...
, validation plans, requirements specifications, IQ/OQ/PQ protocols, traceability matrices, summary reports, and relevant SOPs...
and drive rapid issue resolution. Lead process validation, test method validation, and equipment qualification (IQ/OQ/PQ...
for product changes and process validations (IQ/OQ/PQ), including risk assessments, compliance verification, and coaching teams...
validation planning, executing IQ/OQ/PQ protocols, and final report generation. Act as the primary point of contact...
SOP-driven validations, produce IQ/OQ/PQ deliverables, and ensure ALCOA+data integrity. Perform gap analyses..., FTIR, NMR, Polarimeter, XRD, Kaye Validators, and LIMS/Empower3 systems. Proven expertise in IQ/OQ/PQ protocols, RTM/VSR...
activities (IQ/OQ/PQ where applicable), test summaries, validation summary reports, and release documentation to support system...
manufacturing processes. Perform and analyze IQ, OQ, and PQ qualifications along with other validation activities. Lead PFMEA... medical device industry (pharmaceutical experience not applicable). Hands-on experience executing IQ, OQ, PQ, and conducting...