Validation Engineer II jobs in United States
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HireTalent - Staffing & Recruiting Firm · 3 weeks ago

Validation Engineer II

positionPortsmouth, NH
timeFull-time
remoteHybrid
seniorityMid Level

HireTalent is a staffing and recruiting firm, and they are seeking a Validation Engineer II. The CSV Engineer will identify and implement industry best practices while ensuring compliance with regulatory requirements and industry standards through various improvement projects.

DeliveryHuman ResourcesStaffing Agency

Responsibilities

Identify and implement industry best practices through an extensive industry network and detailed knowledge of applicable regulations
Work with other experienced members of the CSV team to identify roadblocks and additional efficiencies during the scoping portion of improvement projects
Risk assess systems, review change requests and test scripts, draft protocols, and initiate and review GMP documentation revisions
Execute all responsibilities as the CSV owner for significant site and process improvement projects to ensure compliance with appropriate regulatory requirements and industry standards while maximizing efficiency
Perform all aspects of QMS processes – Change Control (particularly associated with DCS (DeltaV) and MES (Syncade) systems), Deviations, CAPAs
Perform other duties as assigned

Qualification

Equipment validationComputer validationControls AutomationProcess Control SystemsManufacturing Execution SystemsBiotech/Pharma experienceDeadline managementAttention to detailIndependent work

Required

Substantial experience in equipment and/or computer validations
Must have working experience with Controls Automation, Process Control Systems, Distributed Systems, Manufacturing Execution Systems (MES) required, DeltaV preferred
Prior experience leading projects in a Biotech/Pharma or biologics industry
Strong attention to detail and ability to work independently and meet deadlines successfully

Preferred

DeltaV preferred

Company

HireTalent - Staffing & Recruiting Firm

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HireTalent is a certified Minority Business Enterprise (MBE) workforce solutions firm, specializing in securing the best talent fits in Executive/Retained Search, Direct Hire Placements, MSP, SOW, and nationwide hiring program management and support.
dateFounded in 1997
location
New York, New York, USA
people-size1001-5000 employees
web-link
http://hiretalent.com

Funding

Current Stage
Late Stage

Leadership Team

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Ashish Kaushal
CEO / Founder
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Company data provided by crunchbase