Validation Engineer (Contract)

The Engineer is actively involved in Commissioning, Qualification, Validation, and Requalification activities for Vertex Cell and Gene Therapy facilities. The individual is responsible for executing qualification protocols at the Vertex 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:

• Develops and executes qualification and validation test plans and protocols for systems such as single-use bioreactors, QC instruments, refrigerators, incubators and autoclaves.
• Develops and executes Environmental Performance Qualifications, analyses results, and generates reports.
• Develops and executes IQ, OQ and PQ qualification protocols for utility systems.
• Develops and executes IQ, OQ and PQ qualification protocols for biosafety cabinets.
• 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.
• Completes Vertex assigned training and ensures that they are 100% compliant 100% of the time.
• 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.

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 (4 for Sr.) 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.