Commissioning, Qualification & Validation Specialist (CQV)

We are seeking Commissioning, Qualification, and Validation (CQV) professionals to support validation activities in a regulated pharmaceutical, biotechnology, or medical device manufacturing environment. This role is open to Engineers, Scientists, and Validation Specialists with experience supporting equipment, utilities, laboratory systems, or facilities qualification.

Requirements

• Support Commissioning, Qualification, and Validation (CQV) activities.
• Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Assist with equipment startup and commissioning activities.
• Author and review validation documentation, including protocols, reports, and discrepancy resolutions.
• Ensure compliance with cGMP regulations, FDA guidelines, and internal quality systems.
• Participate in risk assessments and impact assessments related to validation activities.
• Support change control, deviations, and CAPA investigations when required.
• Collaborate with Engineering, Quality, Laboratory, Manufacturing, and Validation teams.
• Ensure compliance with Good Documentation Practices (GDP) and data integrity principles.

Benefits

• Medical, dental, and vision care
• Comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
• Backup dependent care
• Adoption assistance
• Infertility coverage
• Family building support
• Behavioral health solutions
• Paid parental leave
• Paid caregiver leave
• Training programs
• Professional development resources
• Mentorship programs
• Employee resource groups
• Volunteer activities