CQV Engineer (Commissioning, Qualification & Validation)

PACIV•Indianapolis, IN

2d•Onsite

About The Position

PACIV is seeking a CQV Engineer to join their Indianapolis, IN team. This role will support the commissioning, qualification, and validation of manufacturing systems, equipment, facilities, utilities, and automation systems within regulated pharmaceutical environments. The engineer will work on high-impact capital projects, transforming complex systems into operational, compliant, and production-ready assets. PACIV specializes in Process Automation, Controls, Instrumentation & Validation, delivering world-class solutions to advanced manufacturing clients.

Requirements

Bachelor's degree in Biomedical or Chemical Engineering.
Experience with Commissioning & Qualification (C&Q) deliverables, CQV activities, validation documentation, or relevant academic/project experience.
Strong understanding of validation principles and deliverables, including requirements development, design, testing, and reporting.
Strong interpersonal, verbal, written, and presentation communication skills.
Highly motivated, results-driven mindset with the ability to manage multiple priorities in a fast-paced environment.
Demonstrated project management skills and the ability to independently drive assignments to completion.
Ability to travel up to 40% domestically and internationally.

Responsibilities

Develop and drive completion of Commissioning & Qualification (C&Q) deliverables, including validation plans, risk assessments, project strategies, user requirements, functional specifications, design specifications, impact assessments, traceability matrices, test cases, engineering studies, and final summary reports.
Apply a strong understanding of commissioning and qualification principles to support project execution and regulatory compliance activities.
Support pharmaceutical capital projects for: Active pharmaceutical ingredient (API) manufacturing equipment, Filling operations, Device assembly systems, Packaging equipment, Facilities and utilities, Automation systems.
Participate in project review meetings, including design reviews, qualification reviews, testing strategy discussions, execution reviews, and project status meetings.
Develop, review, and maintain validation and qualification documentation within electronic lifecycle management systems.
Assess, document, and support change management activities resulting from design updates, deviations, and testing outcomes.
Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities.
Complete required client training and site-specific onboarding requirements.
Perform other duties as assigned.