Clean Validation Engineer

2 weeks ago

New York, United States Trinity Consultants Full time

ADVENT's services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

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. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set. This is an outstanding opportunity to join our growing team

Responsibilities Utilize engineering, vendor, and client specifications to generate and execute testing protocols for process equipment and utility systems following client procedures and good documentation practices 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. Qualifications 5 to 12 years of experience in biotech, pharmaceutical, medical device, or academic or environment Cleaning and Process Validation i. Generating/executing validation protocols and authoring final summary reports. Familiarity with upstream and downstream processes and equipment. Working with cross-functional teams (Validation, QC, Engineering, QC, etc.) to develop cleaning and process validation strategies. 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 Experience with testing equipment and software such as Kaye Validators and Dataloggers Engineering or Scientific degree Travel may be required on occasion Permanent FTE or temporary/contract options available

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