CQV Engineer - Commissioning, Qualification & Validation
About The Position
PACIV is seeking a CQV Engineer (Commissioning, Qualification & Validation) to support the commissioning, qualification, and validation of manufacturing systems, equipment, facilities, utilities, and automation systems within regulated pharmaceutical environments. This role involves working on high-impact capital projects to transform complex systems into operational, compliant, and production-ready assets. PACIV specializes in Process Automation, Controls, Instrumentation & Validation, helping clients bring the future of advanced manufacturing to life with automation, validation, and instrumentation solutions.
Requirements
- 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.
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 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
