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Csqe Kensey Warner
System Validation Supervisor at Cellectis
Professional Background
Kensey Warner is a seasoned professional with extensive experience spanning the medical devices, nutraceutical, and pharmaceutical sectors. With a robust background in computerized systems, laboratory operations, manufacturing, method development, quality assurance, and quality control, Kensey brings a wealth of expertise to the industry. Her career has been characterized by a commitment to excellence in various critical areas including packaging, process development, research and development (R&D), and supplier quality management (SQM).
Kensey has demonstrated her strong analytical skills through the development of analytical methods in academic settings, as well as implementing advanced technologies like Raman and FT-IR spectrometry in professional laboratory environments. Her technical proficiency ensures that she effectively addresses and resolves complex challenges within the realm of scientific validation and compliance, particularly in areas pertaining to computer system validation and laboratory equipment validation.
Education and Achievements
Kensey earned her Bachelor of Arts degree in Chemistry from Clemson University, a foundation that has equipped her with a solid understanding of chemical principles and applications. This academic background has significantly contributed to her success in various roles across multiple companies, where she has honed her skills in validation and compliance methodologies.
In her career trajectory, Kensey has held numerous prestigious positions, showcasing her growth and adaptability in the field. Currently, she serves as the System Validation Supervisor at Cellectis, where she oversees system validation processes and ensures adherence to industry standards and regulations. Previously, she had an impactful tenure as a Senior Validation Engineer at Cellectis, further solidifying her reputation as a skilled professional in validation engineering.
Kensey also contributed her expertise as an IS Verification & Validation Representative at bioMérieux, where she was instrumental in the verification and validation of information systems that are critical to the delivery of high-quality products. Her cumulative experience includes roles as Validation Specialist III at Mangan Inc. and Senior Validation Specialist at Barry-Wehmiller Design Group, where she consistently demonstrated her ability to generate documentation and ensure compliance with standard operating procedures (SOPs).
Key Responsibilities & Contributions
Key aspects of Kensey’s responsibilities include the development and execution of GAMP Lifecycle documentation, which encompasses aspects such as specifications, site acceptance tests, factory acceptance tests, and commissioning/decommissioning documentation. Kensey has successfully developed and managed installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols for automated process control systems. Her work in this area is crucial for ensuring compliance with CFR 21 and Part 11 Electronic Records and Electronic Signatures, thereby enhancing the reliability of automated systems in the pharmaceutical and medical device industries.
Moreover, Kensey has played a significant role in establishing acceptance criteria for new suppliers, vendors, and raw materials. This includes executing supplier questionnaire implementation, which is vital for maintaining quality assurance throughout the supply chain. Her meticulous approach to batch record creation and review enhances quality control, confirming that all products meet stringent industry standards before reaching consumers.
Throughout her career, Kensey has continually sought to improve processes and methodologies. Her proactive nature has led to the optimization of laboratory operations and validation processes, promoting operational efficiency and contributing to the success of her teams and organizations.
Achievements
Kensey’s achievements are a testament to her dedication and skills in the field of validation engineering and quality assurance. Her contributions have not only propelled her career forward but have also helped establish best practices within the organizations she has been part of. With a strong focus on compliance and operational excellence, Kensey has helped streamline validation processes and improve product quality through rigorous testing and analytical methodologies. She continues to be a valuable asset in any team, driving continuous improvement and ensuring adherence to industry standards.
Integration into Top Companies
Her broad experience with prominent organizations such as Perrigo and Bausch + Lomb as a SQM Material Scientist and LIMS Analyst respectively showcases Kensey’s adaptability and proficiency in various roles within the pharmaceutical and medical device industries.
In her early days, Kensey contributed as a Raw Material Chemist at Perrigo and as a Chemist at Capsugel, where she laid the groundwork for her extensive expertise and understanding of pharmaceutical materials and processes. These foundational roles provided her the opportunity to engage closely with the development and testing of materials crucial for the industry.
Conclusion
Kensey Warner represents the ideal blend of knowledge, practical experience, and unwavering professionalism, making her a standout figure in the realms of medical devices and pharmaceuticals. Her commitment to quality, compliance, and efficiency, coupled with her impressive track record in validation engineering, positions her as not only a leader in her field but also as a mentor for emerging professionals in the industry.