Maik Guttzeit
Principal Expert C & Q Concepts @Bayer
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WORK HISTORY
Principal Expert C & Q Concepts @Bayer
Leverkusen, DE
EDUCATION
Berlin University of Applied Sciences Berlin (BHT)
Dipl.-Ing.
ABOUT MAIK GUTTZEIT
Available for contractual engagements to strategically support complex aseptic manufacturing projects as a consultant or project manager, ensuring efficient execution, high quality standards, and full regulatory compliance. Experienced leader and globally recognized expert in pharmaceutical engineering with over 20 years of experience across the pharmaceutical industry and equipment suppliers. Specialized in lyophilizer projects (incl. loading/unloading systems, isolators, and fill/finish interfaces), GMP-compliant equipment design, and lean CQV concepts. Combining deep technical expertise with strategic project management, I drive efficient, regulation-compliant project delivery. I actively contribute to international standards (e.g, ASME BPE, ISPE GAMP) and promote pragmatic, standardized approaches that align process efficiency with regulatory requirements. My capacity to integrate industrial demands with technological expertise and regulatory standards is demonstrated through my professional publications, speaking engagements, and leadership experience.
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