CQV Engineer - Commissioning, Qualification & Validation

CQV Engineer (Commissioning, Qualification & Validation)

Location: Raleigh, NC (Hybrid)
Travel: Up to 40% Domestic and International Travel

Bring Critical Manufacturing Systems to Life

PACIV stands for Process Automation, Controls, Instrumentation & Validation.

At PACIV, we help bring the future of advanced manufacturing to life by delivering world-class automation, validation, and instrumentation solutions. Our teams solve complex challenges, support industry-leading facilities, and make a measurable impact on critical manufacturing operations every day.

We are looking for a CQV Engineer
. In this position, you will support the commissioning, qualification, and validation of manufacturing systems, equipment, facilities, utilities, and automation systems within regulated pharmaceutical environments. You will work on high-impact capital projects that help transform complex systems into operational, compliant, and production-ready assets.

PACIV does not provide H-1B sponsorship, H-1B transfers, OPT sponsorship or CPT sponsorship

• 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 involving:
  • 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.

• Bachelor's degree in Biomedical or Chemical Engineering.
• Up to 3 years of 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.

• Work on pharmaceutical manufacturing and life sciences capital projects.
• Gain hands-on experience with commissioning, qualification, validation, FAT, and SAT activities.
• Collaborate with experienced engineering, automation, and validation professionals.
• Build expertise working with manufacturing systems, utilities, facilities, and automation technologies.
• Contribute to projects that support critical manufacturing operations and production readiness.

PACIV offers a competitive compensation package designed to support employee well-being and long-term financial success.

• Generous Paid Time Off:
  Vacation, Sick Leave, and Company Holidays
• PACIV pays 90% of yearly health care premiums
• Health Savings Account (HSA) with Company Contributions
• 401(k) with Company Match up to 4% and immediate vesting with enrollment

• Full-time, direct-hire position
• No Corp-to-Corp (C2C) or 1099 arrangements
• PACIV does not partner with third-party recruiting agencies
• PACIV does not provide H-1B sponsorship, H-1B transfers, OPT sponsorship, CPT sponsorship, or employment-based immigration support.

PACIV is an Equal Opportunity Employer

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