CQV Engineer

Position: CQV Engineer Location: Petersburg, VA Experience: 5+ years

Duration:12+ months contract

Job Overview

This role focuses on leading commissioning, qualification, and validation efforts across facilities, utilities, and equipment within pharmaceutical and biotech environments. You’ll be at the center of project execution, supporting planning, development, documentation, and hands-on validation work while keeping everything aligned with regulatory and quality standards.

Key Responsibilities

Develop and execute commissioning, qualification, and validation protocols for biomanufacturing equipment, utilities, and systems.

Create and maintain documentation such as validation plans, protocols, reports, standard operating procedures, and related lifecycle records.

Identify risks in CQV activities, evaluate their impact, and build practical mitigation strategies.

Troubleshoot equipment, process, and system performance issues and support timely resolution.

Work closely with engineering, manufacturing, quality, and project teams to coordinate CQV activities and timelines.

Ensure all work aligns with applicable regulatory requirements including FDA, EMA, and industry standards such as GMP and GAMP.

Support additional project tasks required to deliver successful validation outcomes.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.

• At least 5 years of CQV experience in sterile pharmaceutical or biotech operations with hands-on commissioning, qualification, and validation.

• Strong understanding of regulatory expectations and industry standard practices.

• Proven experience with isolator systems, aseptic processing, and fill-finish equipment.

• Strong analytical ability and practical problem-solving skills.

• Solid technical writing skills with experience preparing protocols, reports, procedures, risk assessments, and technical specifications.

• Clear communicator with the ability to work well across teams.

• Organized, proactive, and able to manage multiple project priorities.

• High attention to detail with a commitment to quality and compliance.

• Willingness to travel for project assignments as needed, with the flexibility to work effectively across different sites and environments.

• Must be authorized to work in the United States.