Sr Compliance Specialist, Facilities Engineering

FUJIFILM Biotechnologies - College Station, TX

Hiring: Sr Compliance Specialist, Facilities Engineering Company: FUJIFILM Biotechnologies Location: College Station, TX Job Posted Time: 2026-09-16 14:04:17 Target Skills & Keywords : Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Regulatory Compliance, Root Cause Analysis, SCADA About the job Required Skills: •Partner cross-functionally with Facilities Engineering Department staff and site leadership to build a strong quality culture by coaching on GMP principles and the rationale behind them, modeling and reinforcing compliant behaviors in daily operations. •Intake and triage deviations for criticality, impact, and regulatory significance. •Ensure proper record classification, ownership, and timelines per FLBT - QMS requirements. •Lead and facilitate cross – functional root cause analysis (RCA) workshops using structured tools (5-Why, Fishbone, FMEA, Fault Tree, 6M); validate root cause with data, and execute confirmatory tests / analysis as needed •Distinguish true root causes from symptoms; assess human and system factors. •Lead the on-time, compliant closure of Deviations, CAPAs, Effectiveness Check and Change Control for Facilities Engineering. •Initiate deviations, CAPAs, effectiveness checks, and change controls upon request, ensuring compliance and timely progression. •Support Internal and External Audit readiness regarding Facilities Engineering Areas. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!