Quality Engineer – FDA OTC Validation Specialist

SnugZ USA; West Jordan (UT); On-site; USD 85,000 - 100,000; Full time

Job summary

SnugZ USA is seeking a Quality Engineer to lead validation and manufacture‑floor quality improvements in a fast‑paced OTC product environment in West Jordan, UT. You will validate processes, qualify equipment and utilities, and drive CAPA and investigations on a daily basis.

You will partner with Operations to strengthen controls, develop SOPs, and ensure GDP/ALCOA+ documentation for FDA inspections and internal reviews.

Qualifications

• Bachelor's degree in a technical field required.
• 5+ years of quality engineering or validation in FDA-regulated CGMP manufacturing.
• Experience with OTC drug/personal care products is preferred.
• Hands-on experience with process validation, cleaning validation, and equipment qualification.

Responsibilities

• Write, execute, and report process validation protocols for OTC liquid, gel, and semi-solid products.
• Lead cleaning validation and the CVMP for manufacturing and filling equipment.
• Qualify manufacturing and filling equipment and utilities (IQ/OQ/PQ), including RO water systems, maintaining validated state.
• Maintain the validation master plan and validation schedule.
• Be the on-floor quality technical presence, improving process controls and documentation practices.

Skills

Quality engineering

cGMP manufacturing

Root cause analysis

CAPA management

FDA regulations

Process validation

IQ/OQ/PQ

SPC

Documentation

Education

Bachelor's degree in Chemical, Industrial, or Biomedical Engineering, Microbiology, or a related technical field

Tools

Minitab

JMP

Job description

SnugZ USA is seeking a Quality Engineer to lead validation and manufacture‑floor quality improvements in a fast‑paced OTC product environment in West Jordan, UT. You will validate processes, qualify equipment and utilities, and drive CAPA and investigations on a daily basis.

You will partner with Operations to strengthen controls, develop SOPs, and ensure GDP/ALCOA+ documentation for FDA inspections and internal reviews.