Validation Engineer III

Katalyst Healthcares and Life Sciences

Athens, GA

JOB DETAILS
SKILLS
Analysis Skills, Biology, Calendar Management, Change Control, Communication Skills, Continuous Improvement, Corporate Policies, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Documentation, EEO Regulations, Establish Priorities, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), Identify Issues, Leadership, Maintain Compliance, Manufacturing, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Operational Support, Presentation/Verbal Skills, Product/Service Launch, Production Support, Production Systems, Project/Program Coordination, Regulatory Compliance, Regulatory Requirements, Requirements Management, Staff Training, Systems Administration/Management, Team Player, Technical Support, Test Strategy, Time Management, United States Department of Agriculture (USDA), Validation Plan, Writing Skills
LOCATION
Athens, GA
POSTED
Today
Roles & Responsibilities:
  • Independently draft and execute complex validation plans, protocols, and test strategies to ensure compliance and expedited release of critical site equipment.
  • Balance competing priorities while ensuring global work is conducted per regulatory requirements and company procedures.
  • Serve on internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality-related issues and support continuous improvement.
  • Train personnel in quality and validation principles.
  • Support Engineering and other departments in the selection, review, acquisition, and upgrade of systems and production equipment.
  • Provide technical support in developing user and functional requirements specifications (URS, RA, FRS, DQ) for systems and equipment.
  • Act as Lead Validation representative on assigned project teams; communicate new requirements and perform training with Validation team to assure timelines are met for successful project completion and product launches.
  • Share quality philosophies throughout Operations and support Production and Engineering.
  • Perform all company business in accordance with regulations (EEO, FDA, etc.) and company policies.
  • Develop audit responses and complete CAPAs by target due dates; ensure Validation areas are "inspection ready" at all times.
  • Execute actions required to support Change Control, Deviation, and CAPA on-time closure.
Education & Experience :
  • Minimum 6 years GMP validation or similar experience in a GMP manufacturing/production environment.
  • Minimum 10 years GMP validation experience in a GMP or regulated manufacturing environment in lieu of a degree.
  • At least 3 years leading projects.
  • Ability to plan, schedule, organize, prioritize, and coordinate project activities.
  • Ability to function in a leadership role and within cross-functional teams.
  • Ability to analyze validation and production data to assess compliance with GMP requirements and troubleshoot compliance problems.
  • Excellent written and verbal communication skills.
  • Strong comprehension/application of FDA/EU/USDA regulatory requirements for production and distribution of regulated biological articles.
  • Strong theoretical and practical knowledge of regulated processes and one technical discipline (e.g., biology).
  • Ability to make decisions regarding product acceptability based on documentation.
  • Demonstrated ability to work with diverse groups and manage conflict.
  • Proficiency in MS Word, Excel, Outlook, and PowerPoint.
  • Bachelor's degree, preferably in a science or engineering-related field.

About the Company

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Katalyst Healthcares and Life Sciences