Senior GMP Manufacturing Engineer - Onsite Diagnostics Lab

Universal Diagnostics S.A.; Dallas (TX); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

PTO 22 days

Birthday off

Health, dental, vision + life

401(k) retirement plan

Flexible schedule

Job summary

Universal DX is seeking a Senior Manufacturing Engineer to coordinate cGMP manufacturing and stability programs within Manufacturing Operations. You will oversee schedules, sample pulls, testing readiness, traceability, records, and cross-functional follow-up, partnering with FQC Technical Lead and Quality.

The ideal candidate has 5+ years in GMP manufacturing, biopharma, or regulated labs, with hands-on molecular biology/NGS workflows and strong documentation skills.

Qualifications

• GMP manufacturing, biopharma, reagent manufacturing, QC, analytical development, stability, or regulated lab experience.
• Strong scheduling, traceability, documentation, data review, and cross-functional collaboration skills.
• Hands-on molecular biology / NGS workflows experience is preferred.

Responsibilities

• Coordinate GMP manufacturing and stability programs.
• Maintain schedules and testing timelines for stability studies.
• Manage sample storage, inventory, pulls, testing and documentation.
• Escalate unexpected results through quality channels with leadership.
• Support investigations, CAPAs, audits, and data retrieval for FQC stability activities.

Skills

Scheduling

Traceability

Technical documentation

Data review

Cross-functional coordination

Education

Master’s degree or PhD in Life Sciences / related field

Job description

Universal DX is seeking a Senior Manufacturing Engineer to coordinate cGMP manufacturing and stability programs within Manufacturing Operations. You will oversee schedules, sample pulls, testing readiness, traceability, records, and cross-functional follow-up, partnering with FQC Technical Lead and Quality.

The ideal candidate has 5+ years in GMP manufacturing, biopharma, or regulated labs, with hands-on molecular biology/NGS workflows and strong documentation skills.