Rees Scientific

VP of Quality and Validation

Lifecycle Labs

Environmental Monitoring (EM) services for GMP clean rooms.

Investor

Crazy Ventures

Kolbe Certified / Business Coach / Investor 

I started my entrepreneurial journey in 2007 with my brother. Together we grew our company from 2 to 250 people in just a few short years. Making the Inc 5000 list 5 years in a row.

Tommy was able to get out of the day to day of his business and focus on his passion to help entrepreneurs achieve freedom in their own lives.

Chief Adventure Officer | Business Coach | Investor

Washburn Air

Genesis AEC

CQV Services

Azzur

At Azzur, it’s not just about growing in size – it’s about evolving into something much bigger than the sum of our united companies. Our holding company model allows businesses to take advantage of internal services such as marketing, payroll, accounting and HR while staying autonomous.  In addition, Azzur provides advisory, consulting and interim management in the areas of financing, business strategy, sales and marketing, customer acquisition, business development, and capital acquisition. This model permits business owners to participate in the success of other companies by having shared equity in the holding company.  At Azzur, we have proven this type of collaboration drives development, fosters innovation and equates to outsized growth.

Co-Founder

Discovery to delivery. These three words say a lot about what we do.  At Azzur Group, we’ve grown our business around the needs of clients by providing seamless service through every stage of the product lifecycle. Named one of the Inc. 5000 Fastest Growing Companies in America by Inc. magazine, Azzur Group serves the pharmaceutical, biotechnology and medical device industries by offering a variety of consulting services and project resources within the quality assurance, laboratory, clinical trials, IT/IM, business processes, manufacturing, operations, and research and development settings.

Sanofi Pasteur

Consultant

Validation Consultant

GlaxoSmithKline Biologicals

Hi, I'm Thomas O'Donnell, an entrepreneur and business owner with 20+ years of experience in the Pharmaceutical and Biotech industries. My Kolbe MO is 4-4-6-7, and my top five Strengths Finder attributes are Simplifier, Includer, Relator, Futuristic, and Belief, supported by Self-assurance 🌟.

As a dedicated leader in the Healthcare and Life Sciences industry 🌐, I've honed my skills in building start-ups, project management, facilitation, coordination, and team-building, supporting professionals in highly-regulated fields like Pharmaceutical and Biotech.

My unique ability lies in connecting with individuals, understanding their passions, and helping life science service companies grow through collaboration and strategic thinking 💡. I create collaborative environments, fostering open dialogue, knowledge sharing, and innovation, driving success in commissioning, qualification, and validation processes.

I believe that most growth results from taking many small steps 🚶‍♂️🚶‍♀️. Success in pharma, biotech, labs, or validation projects 🧪🔬 often stems from consistent small steps forward. I'm passionate about helping professionals learn about commissioning, qualification, validation, implementing EOS Worldwide, and business development 🚀.

Throughout my career, I've collaborated with renowned clients and stakeholders, effectively coordinating activities for seamless execution of commissioning, qualification, and validation processes, maintaining the highest standards of regulatory compliance.

As a seasoned professional in the Pharmaceutical and Biotech sectors, I'm eager to connect with like-minded professionals and share insights that drive progress in these dynamic fields 🔗. Feel free to reach out to discuss potential opportunities, exchange knowledge, or explore how we can work together to advance the industry and achieve success 🌟.

I enjoy discussing #CQV, #Validation, #Qualification, #ISPE, #entrepreneurship, #eosworldwide, and #startingabusiness.

Keywords: Pharmaceutical, Biotech, Validation, Commissioning, Qualification, EOS Worldwide, Regulatory Compliance, Project Management

Thomas O'Donnell

Quality Agents, LLC

Director Of Operations

Validation Project Manager

Pfizer

•	Authored Installation, Operational, Performance Qualification of the 3 major filling lines (Vial Line 1, Vial Line 2, and Abboject Line) and Integrated line PQs.
•	Authored Project Validation plan, URS, Design Qualification, SOPs, and Summary report for the filling lines.
•	Authored Installation and operational qualification of the Facility and assist in OFCA IQ/OQ execution.
•	Converted all the design documents as per Pfizer policy and regulatory requirements.
•	Generated Test matrix following each URS requirement and Pfizer Quality Policy.
•	Reviewed ETOP, SAT, FAT, Change Controls, Automation Change Controls, Engineering Change Modification, Engineering study, Commissioning, and Validation deviation reports.
•	Responsible for the execution of the IQ, OQ, and PQ of the filling lines (Washer, Trayloader, Puck washer, Depyrogenation Tunnel, Filler, RABS, and Isolators).
•	Member of Major decision-making team, which is responsible for Qualification strategy, Commodity order, line availability, Protocol template, Risk assessment, etc.
•	Responsible for managing a team (2 people/ Filling Line) in order to complete the qualification work in a timely manner.
•	Performed Temperature mapping for the Depyrogenation Tunnel, SIP for the filling lines as part of the OQ.
•	Performed GMP criticality Alarm Assessment for the filling line equipment, Historian Points Criticality Tag assessment.
•	Performed ERES assessment for the Filling lines.
•	Conducted field inspections including piping and equipment walk-downs, operational startup and troubleshooting.
•	Initiated change controls to determine the impact of changes to the facility, utilities, and equipment, as applicable.

Validation Consultant (Azzur Group)

Azzur Group

NOVAVAX INC

Authored and executed Installation and Operational Qualifications for Incubators, Freezers, Refrigerators, LN2 freezer, Multitron, Mixing
tank, Wave bioreactors and Bio-Welders and centrifuges.
Performed Performance qualification for Bioreactors, Mixing tanks and Bio-welders
Performed GAP assessment for the upstream and downstream equipment
Assist vendor in IOQ for the GE AKTA Chromatography system.

MedImmune

•	Performed SIP sanitization and SIP sterilization for buffer hold tanks, formulation tanks using Kaye validator
•	Developed and executed PQ protocol for the Bioreactors , Autoclave, LN2freezer, Incubators, Freezer and WFI water
•	Create a validation master plan for “Device Development” laboratory
•	Performed steam Quality test for autoclave
•	Developed and executed IOQ protocol for the BMS panel, Labx software, Air handler unit, HVAC, Kaye validator, Kaye Valprobes, Metone and Matson Garvin particle size analyzer.
•	Assist vendor for the qualification of TOC, U.V Vis analyzer, vi-cell
•	Developed SOP for steam quality test, Kaye validator operation, Tank SIP sterilization and sanitization
•	Prepared Summary Reports for the Qualifications and Re-qualifications
•	Performed Risk impact determination (RID), Annex 11, 21 CFR part 11 for computerized equipment.

Medtronic

•	Responsible for the development of qualifications and retirement documentation
•	Responsible for conducting and managing field execution of validation deliverables
•	Responsible for monitoring field execution of multiple projects related to validation and manufacturing process.
•	Assist in development and execution of the Cleaning Validation study for the facility equipment.
•	Responsible for generation and execution of Installation Qualification (IQ) and Operational Qualification (OQ) protocols for Implant equipment, Accu sealer, Audion Vac sealer, Fuji sealer, mixing tank, Bubble leak tester, Instron, autoclave.
•	Responsible for developing sop for the autoclave (Getinge, ETC), sealer, and facilities sops as per FDA recommendation.
•	Responsible for the Packaging analysis for Ploytyvek , foil, Kpak pouches.
•	Responsible for revising maintenance plans, Validation master plans (VMP), and standard operating procedures (SOPs) using quality standards set forth by cGMP’s 
•	Assist in FDA and TGA inspection
•	Performed Gage R&R for volumetric liquid, solids and Instron Package tester.
•	Performed Filter Integrity test (Pall Filters)

West-Ward Pharmaceuticals

•	Developed and executed Process Validation Protocol and final execution summary report for different solid dosage forms like tablets and capsules.
•	Responsible for generation and execution Installation Qualification (IQ) and Operational Qualification (OQ) protocols for metal Detector, Deduster, Tablets press, Encapsulator, Capsule check weigher, HVAC system, mixers, tumblers
•	Responsible for developing and execution of the Blend hold time study.
•	PQ for the tablet press, Encapsulator, Metal detector, Capsule checks weigher.
•	Responsible for Managing the process validation improvement projects in 2nd shift
•	Responsible for managing protocol and report development, execution and approval associated with equipment qualification, cleaning validation and process validation. 
•	Executed cleaning validation study for tumbler, fitz mill, and oscillator

Mallinckrodt Pharmaceuticals

•	Prepared Requalification Assessment protocol and executed for departments like blending, coating, tableting, packaging, and encapsulation.
•	Prepared Equivalency report for the Dedusters, V-Blenders, Safe-line metal detectors, Korsch tablets press.
•	Prepared change controls for decommissioning of the equipment
•	Written exception, triage, CAPA for equipment and process failure.
•	Developed Blend hold time study and finished product hold time study protocol for pharmaceutical product.
•	Prepared IOQ for the Kramer Dedusters, totes, and V-blender, Tablet Press and Encapsulator.
•	Performed stability study by using data logger on stability chamber.
•	Developed Process Validation Protocol and Final report for tablets and capsules

Validation Engineer

Novel Laboratories, Inc.

•	Prepared Installation Qualification, Operational Qualification, and Performance Qualification
of autoclaves ,incubators by using Kaye Validator .
•	Developed Cleaning Validation Protocol and calculated MAC for different soils
•	Developed protocol for Requalification assessment of the Equipment
•	Developed/revised procedures (SOPs)
•	Calibrated Thermocouples using Kaye Validator
•	Prepared Summary Reports for the Qualifications and Re-qualifications

Validation Specialist

•	Performed and analyzed Dissolution, Bio-Dissolution, Assay, Blend uniformity, Content uniformity, Impurities of solid dosage forms like Sustained Release Tablets, Capsules, Orally Disintegrating Tablets, Immediate Release Tablets, Suppositories, by using HPLC, Fluorometry, U.V Spectroscopy, IR Spectroscopy, UPLC
•	Calibrated Dissolution bath, PH meter, Bio-Dissolution Bath, and Weighing machines
•	Performed Particle Size analysis by using Malvern(2000S) Particle size analyzer
•	Performed Cleaning Validation and cleaning verification study by using swabs from manufacturing department
•	Conducted stability studies, compatibility studies at different PH condition

AR&D Scientist

Stevens Institute of Technology

• Validation Master Plan for HBD Project
• Performance Qualification of Convection Oven
• Performance Qualification of Deni Press
• Performance Qualification of  Blender
• Process Validation
• Calibration procedure for Moisture analzer

I have over nine (9) years of versatile experience in the pharmaceutical and biopharmaceutical and medical device industry. I possess a strong background in commissioning and validation of manufacturing facilities, laboratory equipment, process utilities and process equipment as well as experience of developing equipment and system specifications, validation master plan, validation test plans, standard operating procedures, and other quality control functions. 
Validation responsibilities include the development and execution of Installation, Operation, and performance qualification Protocols. Experience includes working with Good Manufacturing Practices (GMP) and Good Lab Practices (GLP) by means of Good Documentation Practices (GDP). Working knowledge of cGMPs, GLPs, FDA and ICH guidelines and principles of validation as associated with performance of work for the pharmaceutical and other health-related industries. 
Proficient in using GE Kaye validator 2000, Valprobes, temperature dataloggers for temperature mapping study.
My goal is to enhance my technical skills by applying my practical knowledge and experience in Pharmaceutical, Biotech and Medical device Industry.

taplio

The Battle

Thomas O'Donnell

Amit Jain

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