Gabe Dakowicz
Validation Manager at Lonza
- Role
- Validation Manager at Lonza
- Location
- Portsmouth, NH, US
- LinkedIn followers
- 500 followers
About Gabe Dakowicz
Passionate about developing high-performing validation teams, mentoring future leaders, and influencing cross-functional stakeholders across quality, manufacturing, engineering, and regulatory affairs. My leadership approach emphasizes strategic thinking, practical execution, and building collaborative relationships that enable organizations to scale complex manufacturing operations successfully.I am a validation and quality operations leader with extensive experience in biopharmaceutical and advanced therapy manufacturing, specializing in process validation, equipment qualification, and regulatory compliance within highly regulated GMP environments. My work focuses on ensuring manufacturing systems and processes consistently meet the highest standards of product quality, sterility assurance, and global regulatory expectations.Throughout my career, I have led validation strategies for complex manufacturing technologies including aseptic filling systems, biosafety cabinets, lyophilization processes, and computerized systems. I have a strong background in risk-based validation, airflow visualization studies, environmental monitoring qualification, and process performance qualification (PPQ).I have successfully supported and led teams through regulatory inspections from agencies such as the U.S. Food and Drug Administration and the Medicines and Healthcare products Regulatory Agency, ensuring alignment with global GMP standards and maintaining a culture of compliance and continuous improvement.
Experience
Validation Manager
May 2021 — Present · Portsmouth, NH, US
Education
University of New Hampshire Thompson School of Applied Science
Associate of Science (A.S.), Civil Engineering Technology/Technician
2006 — 2008
University of New Hampshire
Bachelor of Science (BS), Civil Engineering
2008 — 2012
Skills
- Revit
- Computer System Validation
- Gmp
- Cad
- Standard Operating Procedure (Sop)
- Quality System
- Hydrocad
- Osha Certified
- Biotechnology
- Validation
- Engineering
- Capa
- Cip
- U.s. Food and Drug Administration (Fda)
- Pharmaceutical Industry
- Sop
- Fda
- Microsoft Excel
- Commissioning
- Computer-Aided Design (Cad)
- Calibration
- Corrective and Preventive Action (Capa)
- Microsoft Word
- Gxp
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