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.