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. The selected consultant will support protocol development, execution, and validation documentation, ensuring compliance with cGMP regulations and industry standards.

Responsibilities

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

Requirements

Bachelor’s degree in Engineering, Chemistry, Microbiology, Biology, or related scientific discipline; Experience supporting equipment, utilities, laboratory systems, or facilities qualification

Nice to have

2+ years of experience in validation, commissioning, qualification, or regulated manufacturing environments; Knowledge of cGMP regulations and validation lifecycle; Experience supporting IQ/OQ/PQ execution or validation documentation; Strong technical writing and documentation skills; Experience supporting qualification of manufacturing equipment; Experience supporting qualification of laboratory instruments; Experience supporting qualification of utilities systems; Experience supporting qualification of facilities or cleanroom environments

Benefits

Medical, dental, and vision care; Comprehensive suite of wellness benefits; 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