Validation Engineer

The Engineer is actively involved in Commissioning, Qualification, Validation, and Requalification activities Cell and Gene Therapy facilities. The individual is responsible for executing qualification protocols facilities and collaborate with Global Engineering, Facilities Operations, GIS, QA and PMO throughout the life cycle of the project.

This position reports directly to the Manager of Validation.

KEY RESPONSIBILITIES:

The responsibilities of this position may include, but are not limited to, the following:

 Develops and executes qualification and validation test plans and protocols (IOQ, PQ)

 Ensures that all validation documents align with the current Vertex SOPs, global standards and cGMP guidelines.

 Coordinates with personnel onsite and other vendors to schedule and execute test plans.

 If required, coordinates with the construction team and Vertex operations teams to schedule execution of validation activities, safely and effectively.

 Effectively works with cross functional departmental stakeholders, PMO, GIS, EH&S, Global Security, design teams, EHS and QA.

 Supports right-the-first time culture for all documents distributed across the organization.

 Ensures the Global Engineering reputation and partnership is flourished with the cross-functional teams.

MINIMUM QUALIFICATIONS:

 Receptive to change – Adapts (quickly) to changing circumstances.

 Minimum Bachelor’s degree in an Engineering (Chemical, Biomedical, Industrial, Biotechnology) or related

discipline with 2-4 years of CQV experience or equivalent professional experience.

 Self-motivated and must be able to work independently with minimal supervision and direction.

 Experience in developing and executing protocols in GMP industry.

 Experience using Kaye Validator and Data loggers.

 Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP,

ANSI.

 Ability to learn and demonstrate technical problem solving and troubleshooting skills.