Process Team - Lead Engineer
Orders, Service Tickets). Lead and participate in IQ / OQ / PQ activities on process equipment. Act as user representative...
Orders, Service Tickets). Lead and participate in IQ / OQ / PQ activities on process equipment. Act as user representative...
Engineering Change Order and Change Control processes. Collaborate with R&D on OQ and PQ execution and completion for product...
, and change control. Review and approve validation protocols (IQ, OQ, PQ), test methods, and manufacturing documentation...
related to validation activities to multi-functional teams. Generate and execute validation protocols (IQ/OQ/PQ) using Good...
teams on process and product validation activities (IQ/OQ/PQ). Ensure calibration and maintenance programs meet ISO, FDA...
requirements, including PPAPs, Validations (IQ, OQ, PQ), complaints, SCARs, CARs, on-site audits, and product quality requirements...
validation strategy (IQ/OQ/PQ) and ensure revalidation triggers are embedded in change processes. Apply advanced statistical...
and review of DMR/DHR documentation and execution or review of validation protocols (IQ, OQ, PQ). Develop, review, and maintain...
, PQ, TMV or Software Validation for existing products Partners with Global Supply chain, Finished Goods and material..., OQ,PQ and PV plans Excellent written and verbal communication, presentation and interpersonal skills Ability...
(OQ), performance qualifications (PQ), and process performance qualifications (PPQ). Provide technical mentorship...