Universal Diagnostics S.A. · 2 months ago
Staff Manufacturing Engineer
Dallas Fort-Worth
Full-time
Hybrid
Senior Level, Lead/Staff
6+ years expUniversal DX, Inc. is an international company focused on cracking cancer’s code through innovative diagnostic solutions. They are seeking a highly skilled Staff Manufacturing Engineer to lead process development, validation, and optimization within their diagnostic manufacturing operations, ensuring technical excellence and compliance across workflows.
BiopharmaBiotechnologyMedical
Responsibilities
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
Qualification
Required
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
Collaborative leader with strong communication and influencing skills
Passionate about advancing diagnostics through innovation and process excellence
Benefits
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
Relocation support to the DFW area for on-site roles.
And more to come
Company
Universal Diagnostics S.A.
Universal Diagnostics S.A.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$133.51MKey Investors
European Investment BankQuest Diagnostics
2025-02-27Debt Financing· $20.96M
2024-08-19Series B
2023-11-20Series B· $70.22M
Leadership Team
Juan Martinez Barea
Executive President, Founder & CEO
Recent News
Google Patent
2025-05-04
2025-04-02
2025-02-08
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