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

FUJIFILM Diosynth Biotechnologies

CQV Engineering Support

Freeman Contracting and Consulting LLC

Provide Commissioning-Qualification-Validation (CQV), PM and Staff Support Augmentation services to the Pharmaceutical, Medical Device and Biotech Industries

Eli Lilly and Company

Manage/Support Commissioning Qualification and Validation of Parenteral Facility Clean Utilities Execution:
HVAC, PWTR, CSG, WFI, AUTOCLAVES, PARTS WASHERS

C&Q Lead

Thermo Fisher Scientific

Provide Commissioning Qualification Validation (CQV) project support: Author and support execution of SAT, IV, OV, Summary Reports.
Filling Suite associated equipment: Utilities, Vial Washer, Tunnel, filler, Lyophilizer, Parts Washer, Autoclaves, Coder, etc.

Validation Engineer Consultant

Glenmark Pharmaceuticals

Support Validation/Technical services department developing and executing FAT, SAT, IQ/OQ/PQ protocols:
- SAT, IOQ Fette Tablet Compression
- SAT, IOQ, PQ Antaresvision Track & Trace (serialization)
- SAT, IOQ, PQ BWI Water For Injection system
- SAT, IOQ, PQ Tablet Laser Drill system

Review/Remediate Validation documentation as required:
- Review executed test scrips / binders
- Create Summary reports as required

CoImmune Inc.

Provided support to Facility management team following extended facility shutdown: 
Executed equipment validation protocols
Performed lab and facility equipment calibrations

Provided support to Validation/Technical services, developing and executing protocols during startup phase of the following equipment: Manufacturing/Filtration tanks, Autoclaves, Vial Washer,  Depyrogenation Tunnel,  Vial Filler, Lyophilizer, Capper/Sealer, additional support equipment as required.

Genentech

Provided support to Engineering and QA via:
Development and execution of validation protocols for Fluid Bed Processor, Granulation, Parts Washer, etc.

Audentes Therapeutics

Provided support to Engineering and QA departments via development and execution of validation protocols for new and legacy equipment.

Alkermes

Provided Calibration, Facilities, Engineering and QA group support:
• Managed a team of Calibration         Technicians / Calibration Program
• Executed Deviation Investigations
• Authored deviation reports, CAPA's, and change controls for submission to QA Management
• Authored SOP's for new purified water system installation project

Validation Engineer (Metrology) Consultant

Validation consultant, committed to meeting the client's project goals:

Commissioning Qualification Validation:
Trace Matrix (URS, DR/DQ, Verification Strategy, Verification Execution)
    -FAT (Review and Execution)
    -RV, IV/OV, PSSR, CLIA, TOP Review (Development and Execution)
    -Transfer of Care Custody and Control (TCCC)
     -Verification/Qualification Summary Report
   
Project Management/Lead Support:

Quality Assurance support: 
Deviation, CAPA, Change Control, SOP (Development)

Metrology support: 
Program management/instrument calibration
(Development and Execution)

taplio

The Battle

Thomas O'Donnell

Troy Freeman, MPM

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