Commissioning, Qualification & Validation Specialist (CQV)

Cencora

4d•Onsite

About The Position

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Summary of Role: 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.

Requirements

Bachelor’s degree in Engineering, Chemistry, Microbiology, Biology, or related scientific discipline.

Nice To Haves

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, Laboratory instruments, Utilities systems, Facilities or cleanroom environments.

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.