Validation Specialist

2 weeks ago

Greenville, United States Validation & Engineering Group Inc. Full time
Validation & Engineering Group USA, Inc. (V&EG USA) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to working under the highest ethics standards.

Location: North Carolina

Responsibilities:
  • Follow a Risk Based Approach and Testing Strategy.
  • Responsible for the overall delivery and execution of the CQV scope of work including completing all assigned CQV deliverables.
  • Communicate progress on established team meetings.
  • Ability to work independently while maintaining communication with all team members.
  • Requires teamwork, leadership, and influencing skills with a strong focus on customer service.
  • Exposure to typical manufacturing, laboratory, mechanical and warehouse environments.
Qualifications:
  • Bachelor's Degree in Science or Engineering.
  • Minimum of 5 years of experience with commissioning and qualification of aseptic or fill/finish production and packaging systems like:
    • Commissioning & Qualification of Visual Inspection Systems
    • Commissioning & Qualification of Isolators
  • Review and approval of validation lifecycle documentation
  • Excellent communications skills (oral and written) in English.
  • Excellent technical writing skills.
  • Must be proficient using MS Windows and Microsoft Office applications.
  • Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
  • Available to work extended hours, possibility of weekends and holidays, if needed.

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