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 📈

Norman Goldschmidt

Genesis  Architects/Engineers/Constructors

Genesis helps companies expand, adapt, renovate, maintain compliance and enhance sustainability with efficient processes and facilities - We provide the full gamut of A&E and EPCM services; from Strategic Planning, through design and precon to construction management, commissioning and validation. 

Our expertise in regulated industries includes:  cGMP Compliance,Process Engineering, Architecture, MEP/FP Engineering, Risk Management, Strategic Planning and Capital Management Consulting,  to the life sciences, health care and higher education industries.

I am an owner and sit on the Board of directors of Genesis with the other Sr. Principals, setting the strategic direction of the company.

President

ISPE

I am an instructor for ISPE professional development / Training program, delivering multi-day classes on a myriad of topics, including:
Aseptic Process and Facilities
Cell and Gene Therapy
ATMP 
Biotechnology
Environmental Control
and
HVAC

Instructor and Author

ISO - International Organization for Standardization

As a member of US TAG TC-209 I represent the Life Science industry in all matters relating to cleanrooms, environmental control and clean process. I am an author of ISO 14644-4, -16 and -7, as well as the convenor of the standard for separative devices (isolators,RABS, etc). I also represent ISO working groups when speaking/training on ISO cleanroom standards.

ISO Delegate, Author, Convenor

New Jersey Institute of Technology

Professor in the Masters of Pharmaceutical Engineering Program within the Chemical Engineering Department.

Adjunct Professor

NSF International

NSF was the successor company to David Begg and Associates a UK based cGMP consulting and training organization. I provided audit, consulting and training in regulatory compliance for the Life Science industry. Areas of focus include EU compliance, facility / process design, risk management, environmental control, preparation for regulatory inspections,  management of documentation, change management and other issues relating to engineering, construction and maintenance operations.

Consultant

Pharma Engineering Advisors LLC

Help customer firms expand, maintain compliance and enhance sustainability with efficient capital investments - Providing expert design, project management, operations, training and capital management services

Managing Director

Bristol-Myers Squibb

Summary:
Lead cross functional teams responsible for strategic planning and process / facility projects worldwide. Developed and managed a $600MM Capital Plan in collaboration with business units and finance.

Executive Director - Global Engineering

Sr Director Process Engineering and Design

Director Sterile Facilities

Director R&D Facilities

Associate Director Facility Design and Standards

Department Head - Mechanical Engineering

Sr. Manager - Mechancial Engineering & Projects

Manager - Mechanical Engineering & Projects

Innovation Associates

Management of all human resources, customer contact, sales, rendering bids and financial monitoring of all consulting engineering projects.

Director of Engineering

FADCO

Designed Mechanical systems for the Micro Electronics Industry

Mechanical Engineer

Managed the flow of product through the manufacturing process on a day-to-day basis.

Production Control Manager

Genesis AEC supports the Life Sciences from Discovery through Production with Engineering, Architecture, Consulting, Construction, Commissioning, Qualification and Asset Management. 

Our dedicated, innovative and experienced staff combine business insight with technical expertise to deliver projects and services with exceptional value and speed. 

As the President of Genesis I keep the organization aligned with industry trends and needs. I also actively support our clients by leveraging my resources as an Internationally recognized Life Sciences Expert and author with extensive experience in BioPharmaceutical Manufacturing and R&D including: Sterile filling / Vaccine and Biotech API processing / Cell & Gene Therapy / and Global Regulatory Compliance.

My Specialties include:

Management
 - Strategic Planning
 - Energizing and Developing People 
 - Process Improvement / Change Mgmt.
 - Capital Planning
 - Program and Project Management

Technologies
 - Pharmaceutical Manufacturing  Operations, Engineering and Regulation
 - Environmental Control and Compliance
Biotechnology Facilities and Process Integration
 - Cell and Gene Therapy Facilities and Operations
 - Aseptic Facilities and Processes
 - Medical Device industry
 - Pilot Plant Engineering and Regulation
 - Risk Management
 - Sustainability & Energy Conservation
 - Critical Environments / HVAC /Utilities
 - Environmental Monitoring 
 - BMS/ EMS Computer System Validation
 - Facility & Process Validation
 - Validation documentation and Validation activities

taplio

The Battle

Nathan Roman 📈

Norman Goldschmidt

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