Validation & Engineering Group, Inc. (V&EG) 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 work under the highest ethics standards for the following position:

• Project Manager for CQV Documentation Project

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 5 years of experience in Project Management in direct pharmaceutical, medical device or biotechnology industries.
• Experience in CQV in direct pharmaceutical, medical device or biotechnology industries.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows, Microsoft Project 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.

Skills:

• Able to work with multiple projects at the same time.
• At least 5 years on the pharmaceutical industry preferably with experience on CQV Projects, Document Control.
• Efficient scheduling.
• Proactive management.
• Project Management experience.

Project Scope:

The resource should be able to:

• Participate in daily meeting/forums regarding the assigned projects.
• Participate on change control/events meetings.
• Manage change controls to ensure implementation steps are completed on time and in compliance with requirements.
• Participate and serve as facilitator and technical support for the CQV Documentation Project.
• Report immediately any event of the assigned projects.
• Complete event documentation, investigation and closing of implementation actions.
• Perform installation and completeness verification of the activities.
• Coordinate the activities for the day to ensure compliance with schedule and other project requirements.