[Hiring] CQV Validation Engineer @3 Key Consulting

Role Description

Primarily responsible for planning, coordinating, executing, and documenting periodic reviews of GMP equipment to ensure continued state of validation, compliance with regulatory requirements, and suitability for intended use. The role partners with Engineering, Manufacturing, Quality Assurance, Validation, and Maintenance teams to assess equipment performance, maintenance history, calibration status, deviations, change controls, and overall lifecycle management.

Qualifications

• Demonstrable experience in a pharmaceutical, biotech, or life science organization in a C&Q/CQV/validation maintenance role.
• Knowledge of cGMP commissioning/qualification/validation practices.
• Familiarity with biotech/pharmaceutical manufacturing equipment.
• Familiarity with Kneat Gx Platform or other digital C&Q systems.
• Experience working with cross-functional stakeholders.
• Knowledge of quality assurance principles including deviations and change control systems.
• Effective communication skills, both verbal and written.
• Able to think analytically with the ability to resolve issues.
• Able to manage own time efficiently.

Requirements

• Master degree or Bachelor degree and 2 years of experience or Associate degree and 6 years of experience or high school diploma / GED and 8 years of experience.

Benefits

• Pay Rate: $46 - $52/hour W2 with benefits.
• Fully Remote.
• Duration: 12+ months with likely extensions and/or conversion to permanent.

Company Description

3 Key Consulting is hiring a C&Q Validation Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.