Quality Engineer II: GMP/ISO Compliance & Validation

ThermoFisher Scientific

Logan (UT)

On-site

USD 75,000 - 110,000

Full time

6 days ago

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Job summary

Thermo Fisher Scientific is seeking a Quality Engineer II to provide quality engineering support for bioprocessing equipment automation, manufacturing, and quality systems. You'll help ensure products meet customer and regulatory requirements while supporting validation, design control, and continuous improvement initiatives.

The role emphasizes cGMP compliance, audit readiness, and collaboration with cross-functional teams across Engineering, Manufacturing, Validation, and Regulatory Affairs to

Qualifications

Requires knowledge of cGMP, ISO 13485, and 21 CFR Part 820.
Experience implementing CAPA, deviations, nonconformances, change control, and investigations.
Experience collaborating with cross-functional teams in regulated environments.

Responsibilities

Support CAPA, deviations and change control to ensure regulatory compliance.
Assist with IQ/OQ/PQ activities for equipment and processes.
Lead or support investigations using structured problem-solving methods.
Analyze quality metrics and trends to drive continuous improvement.
Collaborate with Engineering, Manufacturing, Validation, Regulatory Affairs, and Operations.

Skills

CAPA

Deviations

Change control

Investigations

Education

Advanced degree in Engineering/Science

Bachelor's in Engineering/Life Sciences with QA experience

Tools

TrackWise QC

SAP QM

Power BI

Job description

The role emphasizes cGMP compliance, audit readiness, and collaboration with cross-functional teams across Engineering, Manufacturing, Validation, and Regulatory Affairs to

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