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Universal Diagnostics S.A.

Staff Manufacturing Engineer

Dallas-Fort Worth, TX
Bioinformatics GMP ISO 13485 FDA CLIA 21 CFR 820 LIMS ERP JMP Minitab SAS Lean Six Sigma
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Description

Staff Manufacturing Engineer

Location: Dallas Fort Worth

Department: Operations

About our Company: 

Universal DX, Inc. is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease’s signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers. 

The Opportunity:

We are seeking a highly skilled Staff Manufacturing Engineer to lead process development, validation, and optimization within our diagnostic manufacturing operations. This role will drive technical excellence and compliance across complex workflows supporting our cfDNA-based multi-cancer detection platform. The ideal candidate combines strong engineering depth with GMP/ISO 13485 rigor and thrives in a fast-paced, mission-driven environment.

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.

 

How you’ll contribute:

• Lead process design, optimization, and validation activities for molecular diagnostic and reagent manufacturing.
• Serve as the subject-matter expert (SME) for core production platforms (liquid handlers, filling systems, lyophilization, or NGS reagent prep).
• Establish process control strategies, monitoring systems, and CAPAs to ensure consistent quality and yield.
• Collaborate with R&D and Quality to enable seamless technology transfer under GMP and ISO 13485 frameworks.
• Oversee complex production campaigns, ensuring compliance, data integrity, and deviation management.
• Provide real-time technical support during manufacturing runs and lead investigations into process deviations.
• Conduct root cause analyses (RCA) and implement corrective and preventive actions.
• Author and review technical reports, batch records, and validation documentation.
• Partner with automation, quality, and software teams to qualify, calibrate, and maintain manufacturing equipment.
• Evaluate and implement new technologies to enhance reliability, throughput, and reproducibility.
• Develop IQ/OQ/PQ protocols and ensure traceable, compliant execution of all equipment qualification activities.
• Ensure all processes align with FDA, ISO 13485, CLIA, and 21 CFR 820 standards.
• Act as process SME during internal and external audits; contribute to CAPA closure and continuous improvement.
• Maintain controlled SOPs, work instructions, and manufacturing documentation.
• Support DHF/DMR updates and risk-management activities.
• Partner with Quality, Supply Chain, and Automation to drive operational excellence and process harmonization.
• Lead Lean or Six Sigma initiatives to improve yield, reduce waste, and standardize processes.
• Influence cross-functional teams to align on best practices and production readiness.
• Train manufacturing specialists and operators in GMP documentation and process control.
• Mentor peers in root cause analysis, data analytics, and structured problem-solving.
• Promote a culture of learning and technical excellence within manufacturing operations.

 

What you’ll bring:

• PhD or MS or BS in Bioengineering, Chemical Engineering, Molecular Biology, or related field.
• 6–8 years of experience in manufacturing or process engineering within IVD, NGS, or biopharma industries.
• Demonstrated expertise in process validation, equipment qualification, and deviation management.
• Strong understanding of GMP, ISO 13485, and FDA/CLIA regulatory frameworks.
• Experience with automation systems, LIMS/ERP platforms, and data analysis tools (e.g., JMP, Minitab, SAS).
• Excellent technical documentation, analytical, and cross-functional communication skills.
• Certification in Lean, Six Sigma, or equivalent process-improvement methodologies.
• Hands-on experience with tech transfer, scale-up, or lyophilized product manufacturing.
• Background in aseptic workflows, robotic liquid handling, or high-throughput reagent prep.
• Analytical, structured, and data-driven problem solver.
• High ownership and adaptability in dynamic, regulated environments.
 

What we´ll offer:

• 22 days of PTO with the possibility to carry over 10 days to the following year. 

• Company Holidays, plus your Birthday off!  
• Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k). 
• Flexible work schedule  
• And more to come! 

 

 

 Why Now? 

This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships.  

We are looking for passionate changemakers to be a part of our journey in this expansive time for us. 

Universal Diagnostics S.A.
Universal Diagnostics S.A.

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