Biopharma Quality Engineer - CAPA & Investigations Lead

Radiometer; Kentucky; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k)

Paid time off

Bonus eligibility

Job summary

Cytiva, a Danaher operating company, seeks aQuality Engineer to support biomanufacturing quality systems on site in Logan, Utah. You will lead investigations, analyze data, and drive CAPAs with cross-functional teams to ensure regulatory compliance and continuous improvement.

The role emphasizes QMS effectiveness, audits, and collaboration across Manufacturing, R&D, and Quality to strengthen product quality and compliance in a fast-paced biopharma setting.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field; minimum 5 years in GMP-regulated environment.
• Strong knowledge of cGMP, ISO 9001/13485; audit readiness and QMS improvements.
• Experience driving CAPAs and quality documentation across teams.

Responsibilities

• Lead Quality Investigations related to deviations, nonconformances, and customer complaints with thorough root-cause analysis.
• Analyze quality data and trends; identify risks and drive CAPAs to improve quality and operations.
• Collaborate with Manufacturing, Operations, R&D, Supply Chain and Quality to support investigations and change controls.

Skills

Quality investigations

Data analysis

Cross-functional collaboration

cGMP knowledge

Audit readiness

Education

Bachelor's degree in Engineering, Life Sciences, or related technical discipline

Job description

Cytiva, a Danaher operating company, seeks aQuality Engineer to support biomanufacturing quality systems on site in Logan, Utah. You will lead investigations, analyze data, and drive CAPAs with cross-functional teams to ensure regulatory compliance and continuous improvement.

The role emphasizes QMS effectiveness, audits, and collaboration across Manufacturing, R&D, and Quality to strengthen product quality and compliance in a fast-paced biopharma setting.