Temperature Mapping Got You Stressed? | Let me help | Follow for Temp Mapping & Validation Insights ✨

Temperature mapping isn’t really about temperature.

It’s about proof.

→ Proof that products were protected.
→ Proof that data can stand on its own.
→ Proof that decisions hold up when it matters most.

Temperature is just the signal.
The outcome is trust.

I help life-sciences organizations design and execute temperature mapping and validation programs that are defensible under audit, repeatable in operations, and clear to explain—years after the work is done.

That includes:

• Temperature mapping and controlled-environment qualification
• Commissioning, qualification, and validation strategy
• Risk-based protocol design and execution
• Data analysis, reporting, and acceptance evaluation
• Training teams to execute work they can defend with confidence

I’ve spent more than two decades working inside regulated environments where tolerance for ambiguity is low and rework is expensive. I’ve supported pharmaceutical, biotech, and life-sciences teams across laboratories, warehouses, cold chain, and controlled-temperature units.

My focus has always been the same.
Turn intent into evidence.

Along the way, I’ve:

• Supported 100+ regulated organizations globally
• Helped reduce validation timelines without lowering standards
• Co-authored industry guidance through ISPE
• Written and taught practical frameworks used in real projects
• Built and scaled validation services grounded in execution, not theory

I’m also the author of Six Steps to Effective Temperature Mapping, a practitioner-focused framework used to train validation and QA professionals on how to plan, execute, and document mapping studies that stand up to scrutiny.

Today, I work independently with companies and teams that want more than compliance language. They want clarity, structure, and results they can explain with confidence.

If you’re responsible for validation, quality, or compliance—and you want work that holds up under pressure—we should talk.

Start with a conversation.
Clarity comes next.

#CQV | #Validation | #Qualification | #ISPE | #Entrepreneurship | #ContentCreation | #TemperatureMapping | #QualityAssurance | #LifeSciences | #ColdChain | #GMPCompliance

Nathan Roman 📈

Rees Scientific

Director of Validation

Genesis AEC

Supporting the Life Sciences industry through Commissioning, Qualification, and Validation of facilities and equipment
•	Lead clients through CQV process providing guidance on cGMP compliance
•	Developing business with new and existing clients
•	Define project timelines, schedules, budgets, cost estimates, and staffing
•	Support, train and mentor a diverse team of internal and external resources. 
•	Develop & execute cGMP compliant documentation for facility systems and laboratory equipment
•	Audit projects designs for cGMP and good engineering practice compliance
•	Perform facility cGMP qualification and validation gap assessments

CQV Project Manager

Solutionwerks, Inc.

Responsible for managing and implementing equipment upgrades and maintenance turnarounds for cryogenic air separation facilities.

Engineering Services Manager

Linde Americas

Led several production, performance, and reliability initiatives at the facility. Key projects include:
•	Overhauled SAP PM system and integrated new $85 million infrastructure project into site plan
•	Implemented new SAP spare parts inventory management program resulting in improved efficiency 
        and minimized delays during unplanned downtime 
•	Managed plant maintenance turnarounds, including developing scopes of work, coordinating 
        schedules, managed contractors and ensuring timely execution of maintenance activities.
•	Project engineer for the construction, integration, and commissioning of a new ASU.

Lead the plant reliability and performance improvement initiative at an Ultra-High purity N2 and O2 plant in Essex Junction, VT
•	Reduced the number and quantity of unplanned downtime events through the improvement of site SOPs and training of personnel
•	Optimized plant performance to increase site reliability and production
•	Performed FMEA assessment to identify and address areas of weakness in equipment sparing
•	Developed valve performance models for ultra-high purity nitrogen plant to identify potential 
        points of failure

Production Engineer

•	Responsible for running multiple air separation plants. Implementing changing in production to meet demand
•	Experience trouble shooting plant upsets/performance issues through trending and KPI reviews
•	Developed the plant KPI email notification system to track plant performance and detect underlying issues
•	Created valve performance models using linear regression to monitor performance and identify potential points of failure

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Nathan Roman 📈

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