Kimberly Byrd work email
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Chemical Engineer experienced in developing, administering and executing validation programs within the Medical Device and Pharmaceutical Industries. Strong knowledge of FDA Regulations; e.g. 21CFR Part 11 & 820, ISO Standards required to comply with current Good Manufacturing Practices (cGMP). Comprehensive working knowledge of project management techniques and tools including estimating, scheduling and resource planning. Proven ability to effectively achieve alignment and consensus, and high quality results across various departments by applying strong leadership and interpersonal skills. Excellent written and oral communication skills that display competence in presenting and conveying information in a professional manner.
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Validation ManagerPfizer Mar 2022 - PresentNew York, New York, Us -
Validation ManagerAlcon Laboratories, Inc. Jan 2013 - Mar 2022Geneva, Switzerland, ChProvide leadership, drive improvement, and implement change to standardize best practices for validation program. Accountable for the qualification and validation of equipment and processes. Develop and execute the Site Validation Master Plan and Periodic Validation Review Program, assuring Site Inspection readiness and alignment with global GxP, Corporate and Regulatory compliance requirements and current industry guidelines -
Associate Director, ValidationMannkind Corporation Jun 2007 - Jan 2013Danbury, Ct, UsDeveloped and managed the Validation Program during the construction, start-up, and qualification of the Commercial Manufacturing facility ($10MM) and ensure compliance with Site Validation Master Plan and relevant ISO, ICH and FDA guidelines in order to meet the timeline for external submission and FDA licensure -
Associate Engineering ConsultantEli Lilly And Company Feb 2004 - May 2007Indianapolis, Indiana, UsManaged the Design/Build portion of the Commissioning & Qualification Program for $350MM Insulin Manufacturing Pen Assembly and Packaging Facility -
Technical AdvisorMerck 1996 - 2004Rahway, New Jersey, UsSupported capital projects, new product development, validation and product launch for established marketing commitments. Directed the design, procurement and construction, scheduling and budgeting activities for all capital research projects ranging from $300K-$3.7MM -
Project EngineerEli Lilly And Company 1989 - 1996Indianapolis, Indiana, UsCoordinated with Project Management, Product and Analytical Development and Regulatory Departments to obtain product definition for selection and evaluation of packaging components and materials. Managed the total planning and implementation process for new construction and renovation of existing facilities in excess of $20MM
Kimberly Byrd Skills
Kimberly Byrd Education Details
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Georgia Institute Of TechnologyChemical Engineering -
Spelman CollegeChemistry
Frequently Asked Questions about Kimberly Byrd
What company does Kimberly Byrd work for?
Kimberly Byrd works for Pfizer
What is Kimberly Byrd's role at the current company?
Kimberly Byrd's current role is Validation Manager at Pfizer.
What is Kimberly Byrd's email address?
Kimberly Byrd's email address is ki****@****con.com
What schools did Kimberly Byrd attend?
Kimberly Byrd attended Georgia Institute Of Technology, Spelman College.
What skills is Kimberly Byrd known for?
Kimberly Byrd has skills like Validation, Fda, Gmp, Gxp, 21 Cfr Part 11, Pharmaceutical Industry, Computer System Validation, Change Control, Capa, Quality Assurance, Manufacturing, Biotechnology.
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