Facilities Engineering Compliance Lead

FUJIFILM Holdings America Corporation

College Station (TX)

On-site

USD 90,000 - 130,000

Full time

6 days ago

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Job summary

FUJIFILM Biotechnologies Texas is seeking a Sr Compliance Specialist - Facilities Engineering to ensure all facilities, utilities, and critical systems stay in full regulatory compliance. This role leads deviations, CAPAs, effectiveness checks and change controls while maintaining robust documentation and training.

Working cross-functionally with Engineering, EHS, Quality, and Operations, you will drive timely closure of records, support audits, and mentor staff to achieve 100% on-time

Qualifications

Bachelor’s Degree in Engineering, Life Sciences, or related field with 8 years’ pharma/regulatory experience.
Master’s Degree in Engineering, Life Sciences, or related field with 6 years’ pharma/regulatory experience.
Equivalent combinations of education and experience will be considered.

Responsibilities

Lead deviations, CAPAs, and change controls for Facilities Engineering.
Coach on GMP principles and drive on-time closure of investigations.
Support internal/external audits and DRB/CRB/CCRB board activities.
Author/revise SOPs and training in the eQMS (eQMS documents).
Review URS/IQ/OQ/PQ protocols for facilities/ utilities/ equipment.

Skills

cGMP knowledge

Communication skills

Analytical skills

Quality management

Deviation management

TrackWise

Veeva

MS Office

Independent work

Education

Bachelor’s Degree in Engineering or Life Sciences

Master’s Degree in Engineering or Life Sciences

Tools

TrackWise

Veeva

CMMS

SCADA

Job description

Working cross-functionally with Engineering, EHS, Quality, and Operations, you will drive timely closure of records, support audits, and mentor staff to achieve 100% on-time

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