Senior GMP Manufacturing Engineer - Stability Oversight

Universal Diagnostics; Fort Worth (TX); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

22 days PTO

Birthday off

Medical, dental, vision insurance

401(k)

Flexible work schedule

Job summary

Universal DX, Inc, based in Texas, seeks a Senior Manufacturing Engineer to coordinate cGMP manufacturing and stability programs on site. You will oversee schedules, sample pulls, testing readiness, traceability, and cross-functional follow-up with the FQC Technical Lead and Quality.

Ideal candidates have 5+ years in GMP/manufacturing environments and hands-on molecular biology or NGS workflows. Join a fast-growing company building a multi-cancer diagnostic platform with ambitious societal

Qualifications

• Master’s or PhD in Life Sciences, Bioengineering, Chemical Engineering or related field.
• Typically 5+ years in GMP manufacturing, biopharma, reagent manufacturing, QC, analytical development, stability, or regulated labs.
• Hands-on experience with molecular biology and/or NGS-related workflows; QC testing experience is preferred.
• Experience coordinating stability studies, sample inventories, scheduled pulls, laboratory testing, or similar time-point driven programs.

Responsibilities

• Coordinate cGMP manufacturing and stability programs.
• Develop and maintain FQC and stability schedules, including sample-pull and testing timelines.
• Coordinate stability sample storage, inventory, pulls, testing, and documentation.
• Ensure stability activities follow approved protocols and defined time points.
• Maintain stability study records, trackers, sample inventories, and traceability.
• Monitor FQC and stability data for trends and execution risks.
• Coordinate technical review of unexpected results with QA and FQC Lead.
• Support preparation and completion of stability protocols and reports.
• Provide visibility into upcoming FQC/stability requirements and milestones.
• Support improvements of FQC and stability workflows and scheduling.
• Collaborate with Manufacturing, Quality, R&D and others to ensure readiness.

Skills

GMP Manufacturing

Stability Programs

Scheduling

Traceability

Technical Documentation

Cross-functional Coordination

Data Review

Problem Escalation

Education

Master's or PhD in Life Sciences, Bioengineering, Chemical Engineering or related

Tools

NGS workflows

Job description

Universal DX, Inc, based in Texas, seeks a Senior Manufacturing Engineer to coordinate cGMP manufacturing and stability programs on site. You will oversee schedules, sample pulls, testing readiness, traceability, and cross-functional follow-up with the FQC Technical Lead and Quality.

Ideal candidates have 5+ years in GMP/manufacturing environments and hands-on molecular biology or NGS workflows. Join a fast-growing company building a multi-cancer diagnostic platform with ambitious societal