Quality Engineer – GMP Biopharma, CAPA & Audits

Hbcu Connect, Llc; Logan (UT); On-site; USD 70,000 - 100,000; Full time

Job summary

Cytiva, a Danaher operating company, is seeking a Quality Engineer to provide quality engineering support for biomanufacturing operations at the Logan, Utah site. The role focuses on investigations, CAPA, and QMS enhancements to ensure regulatory compliance and product quality.

Ideal candidates hold a life sciences or engineering degree with 5+ years GMP experience, strong problem-solving and written communication, and the ability to work on-site in Logan.

Qualifications

• Bachelor's degree in a technical field or related experience in GMP manufacturing.
• Minimum 5 years in a GMP-regulated environment with exposure to quality systems.
• Experience supporting investigations, CAPA, and quality activities is required.

Responsibilities

• Lead investigations related to deviations, nonconformances, and complaints with thorough root cause analysis.
• Analyze quality data to identify trends and drive CAPAs and improvements.
• Collaborate cross-functionally with Manufacturing, Operations, R&D, Supply Chain, and Quality teams.

Skills

Quality Assurance

Audit readiness

Data analysis

Technical writing

Education

Bachelor's degree in Engineering or Life Sciences

Minimum 5 years GMP-regulated experience

Job description

Cytiva, a Danaher operating company, is seeking a Quality Engineer to provide quality engineering support for biomanufacturing operations at the Logan, Utah site. The role focuses on investigations, CAPA, and QMS enhancements to ensure regulatory compliance and product quality.

Ideal candidates hold a life sciences or engineering degree with 5+ years GMP experience, strong problem-solving and written communication, and the ability to work on-site in Logan.