CQV Engineer (Commissioning, Qualification & Validation)Location: Indianapolis, IN
Travel: Up to 40% Domestic & International Travel
We are looking for a
CQV Engineer to join our
Indianapolis, IN team. 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.
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.
Qualifications- 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.
Why Join PACIV- 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.
Compensation & BenefitsPACIV 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
Also Known AsCQV Engineer, Commissioning Engineer, Qualification Engineer, Validation Engineer, C&Q Engineer, Commissioning & Qualification Engineer, Pharmaceutical Validation Engineer, GMP Validation Engineer, Capital Projects Validation Engineer.
#LI-DNI
