Validation / CQV Engineer (Commissioning, Qualification & Validation)

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