VALIDATION SPECIALIST

Fresenius Kabi-posted 10 months ago
$30 - $35/Yr
Full-time • Entry Level
Wilson, NC
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The Validation Specialist works to support site validation technical experts on specific project teams. The Validation Specialist will participate in the development and execution of test plans for manufacturing equipment and processes, utilities, and facilities. The incumbent will contribute as a key validation representative in support of project team activities and process design to ensure cGMP compliance and interdepartmental consistency to the site validation master plan and strategy.

  • Prepare, review, execute, and summarize validation protocols (Installation Qualification, Operational Qualification, Performance Qualification, Investigational/Development Studies) for aseptic pharmaceutical manufacturing.
  • Use of validation metrology equipment.
  • Document validation plans and protocols (tests) to provide objective evidence that equipment, processes, and product meet requirements and are compliant with applicable regulations.
  • Serve as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention.
  • Conduct validation testing for new products and process improvements.
  • Interact with individuals from different disciplines (Engineering, Laboratory, and Operations) to plan, execute, and complete validation activities.
  • Ensure validation efforts are conducted in an appropriate and timely manner.
  • Perform risk assessment exercises in support of validation activities.
  • Prepare Technical Packages and assessments for product transfers.
  • Ensure compliance to company documents, programs and activities related to Health, Safety, Environment, Energy, and Quality Management Systems.
  • AS/AA degree in related field; science, engineering, or manufacturing technology with 3+ years of relevant experience -or- BS/BA degree in related field; science, engineering, or manufacturing technology.
  • Strong interpersonal and project management skills.
  • Must be able to interact effectively at all levels of the company and handle confidential and sensitive information appropriately.
  • Ability to work both independently and in partnership with others, proven ability to demonstrate leadership and use initiative and drive to achieve results.
  • Strong conflict resolution skills.
  • Expertise in Microsoft Office applications, including Word and Excel, and data entry experience a plus.
  • Must be able to work multiple shifts as needed to meet deadlines.
  • 401(k) plan with company contributions.
  • Paid vacation, holiday and personal days.
  • Employee assistance program.
  • Health benefits including medical, prescription drug, dental and vision coverage.
  • Life insurance.
  • Disability insurance.
  • Wellness program.
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