Senior CQV Engineer

4 hours ago

Brisbane, Queensland, Australia PSC Biotech Full time $100,000 - $120,000 per year

POSITION SUMMARY:We are looking for a Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our team on a 12 -month contract.The Senior CQV Engineer is responsible forensuring systems, facilities, and equipment meet design requirements to be putin place for a facility. The incumbent is also responsible and accountable forthe execution of the PSC mission, "to maintain the integrity andprofessionalism of our products and services while enabling steady growth anddevelopment." Act as alead and simplify CQV functions, reports, and processes.Supportimplementing safety programs for major capital projects. Commission,qualify, and validate facilities, utilities, and/or equipment in assignedprojects.Initiates,authors, revises, reviews, and completes controlled documents for CQV projects.Reviewand qualify equipment for commissioning, qualification, and validationactivities.Writesand reviews GMP and GDP documents and technical specifications.Collaboratewith multiple departments on assigned project activities and deliverables.Initiateand coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ,Contactand work with contractors and vendors on assigned projects.Abilityto travel as needed.Additionalduties and responsibilities may be assigned from time -to -time. RequirementsBachelor's Degree in Engineeringor Life Science.7 -10 years of applicable workexperience in the biomedical and pharmaceuticals industry.Proficient in authoring andexecuting DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.Proficient in developing SOPS,final reports and validation & quality policies.Strong experience developing andexecuting CQV protocols.Strong experience creating andmaintaining CQV policies and processes.Has good understanding andcomplies to cGMPs and CFR21 Part 11 guidelines.Demonstrated strategic thinkingand implementation skills; proven analytical skills with ability to translate.Data to actionable plans; demonstrated ability to develop and implementmarketing and product/service. strategies by converting them into tacticalmarketing plans; execute and deliver results.Excellent presentation andcommunication skills, written and oral, for a variety of audiences.​Highly organized in planning andtime management, with the ability to multi -task.

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