Senior Facilities Compliance Engineer

Merck & Co.

College Station (TX)

On-site

USD 90,000 - 140,000

Full time

14 days+
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Job summary

FUJIFILM Biotechnologies Texas in College Station, TX, seeks a Sr Compliance Specialist to ensure facilities, utilities, and critical systems meet cGMP and internal standards.

You will lead deviations, CAPAs, change controls, root-cause analysis, and training, partnering with EHS, Quality, and Operations to sustain control and timely close records.

This role requires strong written and verbal communication, documentation discipline, and ability to work across shifts as needed.

Qualifications

  • Bachelor's Degree in Engineering, Life Sciences, or related field.
  • 8+ years in pharmaceutical or other regulated industry; QA/Compliance experience preferred.
  • Equivalent combinations of education and experience will be considered.
  • Experience with QA systems and audits is a plus.

Responsibilities

  • Coach on GMP principles and promote a compliant quality culture.
  • Lead deviations, CAPAs, change controls, and RCA workshops.
  • Ensure timely closure of records per QMS requirements.
  • Support audit readiness for Facilities Engineering.
  • Maintain and improve documentation in eQMS and CMMS.
  • Lead and/or support deviation/investigation activities and document findings.

Skills

GMP principles
Quality culture
Deviations management
CAPA handling
Root cause analysis
Change control
Documentation discipline

Education

Bachelor's Degree in Engineering or Life Sciences
Master's Degree in Engineering or Life Sciences

Tools

TrackWise
Veeva
CMMS
MS Office

Job description

FUJIFILM Biotechnologies Texas in College Station, TX, seeks a Sr Compliance Specialist to ensure facilities, utilities, and critical systems meet cGMP and internal standards.

You will lead deviations, CAPAs, change controls, root-cause analysis, and training, partnering with EHS, Quality, and Operations to sustain control and timely close records.

This role requires strong written and verbal communication, documentation discipline, and ability to work across shifts as needed.

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