What are the responsibilities and job description for the Validation / CQV Engineer (Commissioning, Qualification & Validation) position at PACIV?
Validation / CQV Engineer (Commissioning, Qualification & Validation)
Indianapolis, IN | Up to 40% Travel
Help Bring Critical Manufacturing Systems Online
We are looking for a Validation / CQV Engineer to join our Indianapolis, IN team to support commissioning, qualification, and validation activities for pharmaceutical manufacturing facilities, equipment, utilities, and automation systems. This is an opportunity to work directly on major capital projects and play a hands-on role in taking systems from installation through production readiness.
If you enjoy solving technical challenges, working in highly regulated environments, and seeing projects come to life in the field, we would like to talk with you.
PACIV does not provide H-1B sponsorship, H-1B transfers, OPT sponsorship or CPT sponsorship
What You Will Work On
✅ Pharmaceutical Manufacturing Capital Projects
✅ API Manufacturing Systems
✅ Filling & Packaging Equipment
✅ Device Assembly Operations
✅ Clean Utilities & Facility Systems
✅ Process Automation & Controls Systems
What You Will Do
- Lead and execute commissioning and qualification activities for manufacturing systems and equipment
- Develop and review validation documentation, protocols, risk assessments, and summary reports
- Participate in FATs, SATs, startup activities, and system turnover
- Support requirements gathering, design reviews, traceability, and testing strategies
- Partner with engineering, operations, quality, and project teams to ensure systems meet regulatory and operational requirements
- Support change controls, deviations, investigations, and project documentation
- Drive projects to completion while maintaining compliance with pharmaceutical industry standards
What Makes You a Strong Candidate
- Engineering degree in Chemical, Biomedical, Mechanical, Electrical, Industrial Engineering, or a related discipline
- Experience supporting CQV, validation, commissioning, qualification, or manufacturing projects
- Understanding of validation lifecycle principles
- Strong technical writing and documentation skills
- Ability to manage multiple priorities in a fast-paced project environment
- Willingness to travel up to 40%
Preferred
- Pharmaceutical, biotech, medical device, or regulated manufacturing experience
- FAT/SAT participation experience
- GMP, GDP, FDA, or cGMP knowledge
- Utilities, facilities, process equipment, packaging, or automation validation experience
- Experience supporting capital projects
Why Engineers Join PACIV
At PACIV, you are not confined to a single production line or facility. PACIV engineers gain exposure to multiple facilities, technologies, manufacturing processes, and capital projects. You will work alongside experienced CQV, automation, and engineering professionals.
- Commissioning and startup activities
- Pharmaceutical capital projects
- Manufacturing technologies
- Automation and controls systems
- Multiple sites and engineering disciplines
- Experienced CQV, automation, and validation professionals
Compensation & Benefits
- Competitive salary
- 90% company-paid healthcare premiums
- HSA with company contributions
- 401(k) with company match up to 4% & Immediate vesting
- Paid vacation, sick time, and company holidays
Important Hiring Information
- 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