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Validation Engineer

Validation EngineerDepartment: EngineeringLocation: Centennial, COEmployment Type: Full-TimeCompensation: $35-$40 per hour DOEWe're looking for a driven and detail-oriented Validation Engineer to support pharmaceutical manufacturing operations and ensure equipment and processes meet the highest industry and regulatory standards. The ideal candidate will be hands-on and solutions-focused, with a strong understanding of cGMPs and validation protocols. This role requires a professional who can work across departments, contribute to cleanroom and equipment certifications, and provide technical support throughout the validation lifecycle. If you have a passion for precision and quality in a regulated environment, we'd love to meet you.Key ResponsibilitiesValidation & DocumentationDevelop, write, and maintain validation protocols, reports, and SOPs in compliance with FDA, USP, and cGMP requirementsCoordinate and execute equipment and process qualificationsMaintain full documentation throughout the validation lifecycleSupport cleanroom certification and recertification every six monthsEquipment & Process SupportAssist with sourcing and validating new equipmentMonitor and resolve equipment and production issuesEvaluate current equipment and procedures for compliance and efficiencyCommunicate with vendors for equipment setup, troubleshooting, and repairFacility Support & ComplianceEnsure all activities align with cGMPs, safety regulations, and internal SOPsSupport facility maintenance and participate in internal/external auditsPerform duties of a Manufacturing Technician as needed, including equipment operation, batch record documentation, and adherence to all regulatory requirementsQualificationsRequired:Bachelor's degree in Engineering (Chemical, Mechanical, Manufacturing, Electrical, or Software)Understanding of scientific and mathematical principlesStrong verbal and written communication skillsProficiency in Microsoft Word and ExcelAbility to read and follow SOPs, cGMPs, and regulatory guidelinesPreferred:2-4 years of validation experience in pharmaceutical or life sciences industryExperience with technical writing and document creationMechanical aptitude and hands-on troubleshooting experiencePhysical DemandsMust be able to work on-site in a cleanroom environmentMay require standing for extended periods and moving equipment during validation proceduresBenefitsCompany-paid health, dental, and vision insurance401(k) plan with employer matchPaid holidays and Floating holidaysTuition ReimbursementRTD EcoPass for public transportationOpportunities for professional growth and developmentEqual Opportunity Employer

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