Apply on Employer Site

Trinity Consultants - Advent Engineering · 6 hours ago

CQV Engineer

Greater Seattle Area

Full-time

Onsite

Senior Level

5+ years exp

Trinity Consultants - Advent Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities, focusing on generating and executing testing protocols and ensuring regulatory compliance.

ConsultingInformation TechnologyLegal

Hiring Manager

Ana Bonilla

Responsibilities

Utilize engineering, vendor, and client specifications to generate and execute testing protocols for process systems, process equipment and utility systems following client procedures and good documentation practices

Experience with gene therapy / cell therapy is a plus

Assist in deviation root cause analysis and corrective action plans

Generate final and summary reports for executed test protocols

Provide technical and compliance input into project execution strategies to ensure regulatory requirements are met

Generate and support higher level project documentation as required such as Masterplans, schedules, and summary reports

Working in the full range of Biotech/pharma project phase execution including all design phases, construction, startup, CQV, and project hand-over activities

You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and ADVENT resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc

Qualification

Commissioning protocolsValidation protocolsRisk based methodologiesBiotech experienceEngineering degreeOffice softwareTesting equipmentTechnical writing

Required

5 to 20+ years of experience in biotech, pharmaceutical, medical device, or academic or environment

Experience writing and executing commissioning, verification, and validation protocols and associated reports

Familiar with integrated commissioning and validation as well as ASTM E2500 verification methods

Experience utilizing risk based methodologies in testing

Experience with manufacturing processes and equipment such as CIP/COP systems, filtration skids, chromatography, fermentors/bioreactors, sterilization, and lyophilization equipment

Experience with hygienic utility systems such as purified water, WFI, clean steam, and process air

Experienced with Office software such as Word and Excel

Engineering or Scientific degree