About me
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With over a decade of experience in the pharmaceutical industry, I have developed specialized expertise in Clean Utilities operations, compliance, engineering, and documentation.
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This consultancy is a part-time project driven by my passion for Clean Utilities and my commitment to supporting the pharmaceutical industry with high-quality, GMP-compliant documentation.
Mark K. Teglman
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Clean Utility Specialist
At Bavarian Nordic, my responsibilities encompasses ensuring the regulatory compliance of Clean Utility systems and processes. I also lead the engineering and qualification of both new installations and refurbished systems. This involves defining system requirements and specifications, coupled with effective project coordination to ensure successful implementation.
Senior Utility Engineer
In a multifaceted role as both Work Package Owner (WPO) and clean utility engineer, I played a pivotal part in guiding the design of comprehensive utility systems for new production facilities. This included actively defining and intricately engineering key components, to match the clients requirements.
My approach involved close collaboration with clients to thoroughly understand their specific needs, ensuring the tailored development of utility solutions for their new facilities.
Clean Utility Specialist
During my tenure at Novo Nordisk, I served as the central point for Clean Utility requirements on a global scale. A key responsibility involved interpreting cGMP requirements for worldwide implementation. In this capacity, I refined my skills in crafting clear and precise GMP documents, collaborating with production sites across the globe.
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Clean Utility Specialist
In my role, I ensured the implementation of correct maintenance plans for all utility systems, concurrently ensuring that clean utility systems remained in compliance. A substantial aspect of this position involved close collaboration with production departments, gaining a comprehensive understanding of their requirements during the rebuilding of clean utility systems. Troubleshooting complex systems was also a critical component, ensuring uninterrupted production by swiftly addressing and resolving any operational challenges.
Clean Utility Specialist
At Statens Serum Institute, the Danish government's vaccine producer and research facility, I held a key role in overseeing the operations, maintenance, and ensuring compliance of all Clean Utility systems. This encompassed proactive troubleshooting, addressing deviations, and managing changes within the systems to ensure seamless and compliant operations.