Professional Overview:
A dedicated and detail-oriented Validation Engineer with a wealth of experience spanning biotech, medical device, pharmaceutical, and GMP environments. Recognized for adeptly functioning both as a collaborative team member and as an independent worker, possessing strong leadership and organizational capabilities. Known for effective communication, problem-solving, and commitment to implementing solutions.
Core Competencies:
GMP Technical Writing: Accumulated 15 years of expertise in crafting essential documentation including Risk Assessment templates, Master Plans, Protocols, Reports, SOP’s, and CAPA Program forms, showcasing meticulous attention to detail and compliance.
Gap Analysis & Risk Assessment: Proficient in conducting thorough Gap Analyses and Risk Assessments in alignment with ICH (Q8, Q9, Q10) guidelines. Certified Lean Six Sigma, emphasizing a commitment to quality and continuous improvement.
Production Leadership: A seasoned Production Team leader with 17 years of experience, adept at guiding and motivating teams toward operational excellence.
Qualification and Validation: Holds 18 years of hands-on experience in the Qualification and Validation of Facilities, Utilities, Equipment, Cleaning, and Process. Additionally, proficient in Manufacturing Scale-Up processes.
Technical Services & Management: With 12 years of expertise, adept in Technical Services & Management functions, demonstrating a comprehensive understanding of industry practices and compliance requirements.
Educational Instruction: Possesses 15 years of experience as an instructor, educating manufacturing personnel and upper management on current FDA regulatory requirements, reflecting a commitment to knowledge dissemination and compliance adherence
Personal Philosophy:
A proactive professional who actively seeks out development and learning opportunities, committed to staying abreast of evolving industry standards and best practices. Embraces challenges and effectively follows through with feedback-driven solutions.