LL01-250718 CQV Project Coordinator for GMP Utilities project

Job Description

Job Description

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:

• CQV Project Coordinator

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 8 years of project coordination experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in GMP Utilities and Facilities new construction.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows, Microsoft Office applications and Scheduling such as Microsoft Project, Primavera.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Strong knowledge of GMP Operations.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities:

• Creating long- and short-term plans, including setting targets for milestones, adhering to deadlines and coordinating activities between all areas of GMP operations for a GMP Utilities project (Validation, Construction, QA, Engineering, Maintenance, SOP, Trainings, Laboratory)
• Delegating tasks on the project to employees best positioned to complete them
• Identifying and managing potential risks and liabilities of the projects
• Assisting in the definition of project scope and goals
• Making effective decisions when presented with multiple options for how to progress with the project
• Serving as a point of contact for teams when multiple units are assigned to the same project to ensure team actions remain in synergy
• Communicating with executives or the board to keep the project aligned with their goals
• Performing quality control on the project throughout development to maintain the standards expected
• Adjusting schedules and targets on the project as needed
• Motivating people involved in the project to complete tasks on time.