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Medix™ · 2 weeks ago

Process Validation Engineer Consultant - 248979

Fargo, ND

Full-time

Onsite

Senior Level

$70/hr - $90/hr

5+ years exp

Medix™ is a consulting firm focused on the biologics manufacturing sector, and they are seeking a Process Validation Consultant to support upstream and downstream process validation activities. The role involves executing process validation lifecycle activities, authoring key documentation, and collaborating with cross-functional teams to ensure compliance with regulatory standards.

CrowdsourcingRecruitingSocial NetworkStaffing AgencyVenture Capital

Responsibilities

Execute process validation activities across the full validation lifecycle for biologics manufacturing

Support upstream and downstream manufacturing processes, including chromatography operations and parameter evaluation

Author and review validation documentation, including Validation Master Plans (VMPs), protocols, reports, risk assessments, and PFMEAs

Perform data analysis and support validation studies for clinical phase manufacturing (Phase 1–3)

Collaborate cross-functionally with manufacturing, quality, and technical operations teams

Support regulatory inspections and internal audits during 'pockets of intensity'

Ensure validation activities are aligned with current regulatory expectations and industry best practices

Qualification

Process validationBiologics manufacturingValidation Master Plans (VMPs)Chromatography processesTechnical writingTeam integrationVerbal communicationFast-paced environment