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PSC Biotech® Corporation · 3 hours ago

Senior Validation Engineer

San Diego, CA

Full-time

Hybrid

Mid, Senior Level

$100K/yr - $130K/yr

5+ years exp

PSC Biotech® Corporation provides expert engineering, technical, and consulting services to the life sciences industry. They are seeking a skilled Validation Engineer to focus on the commissioning, qualification, and validation of computerized systems and facility equipment in GxP-regulated environments.

BiotechnologyConsultingLife ScienceProject ManagementQuality AssuranceRental

Growth Opportunities

No H1B

Responsibilities

Support and execute the validation lifecycle for GxP computerized systems, utilities, and facility equipment

Author and review CSV documentation, including URS, risk assessments, IQ/OQ/PQ protocols, and summary reports

Utilize building automation platforms (e.g., Siemens Desigo) to track facility conditions, equipment alarms, and system performance

Coordinate CQV activities for HVAC, plumbing, clean utilities, and environmental monitoring systems

Manage change controls, deviations, and CAPAs related to facility systems and automation platforms

Collaborate with cross-functional teams, vendors, and contractors to ensure alignment with project timelines and regulatory expectations

Provide technical guidance during audits and inspections, ensuring documentation and systems meet compliance standards

Qualification

Validation engineeringSiemens DesigoGxP complianceGAMP 5Technical writingProject coordinationSoftware validationHardware validationCommunication skills

Required

Bachelor's degree in engineering or a related technical discipline

5+ years of experience in validation engineering, with emphasis on facility systems and building automation in the pharmaceutical/life science industry

Proficiency in Siemens Desigo or similar building management systems

Strong understanding of GAMP 5, 21 CFR Part 11, and GxP compliance

Experience with both software and hardware validation activities

Excellent technical writing, communication, and project coordination skills

Travel is required

Must be authorized to work in the US

No C2C at this time