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Validation Engineer III
Validation Engineer IIIKatalyst HealthCares & Life Sciences • Athens, GA
Validation Engineer III

Validation Engineer III

Katalyst HealthCares & Life Sciences • Athens, GA
[job_card.variable_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

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 years GMP validation or similar experience in a GMP manufacturing / production environment.
  • Minimum years GMP validation experience in a GMP or regulated manufacturing environment in lieu of a degree.
  • At least 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 (, 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.
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