Job Details

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.