CQV Engineer

## Description

**CQV Engineer (Commissioning, Qualification & Validation)

Travel Required - Local & Nationwide

Join the Mission Behind Life-Changing Therapies**

At VaLogic Bio, we don't just support compliance-we empower innovation. Our work allows scientists and biotech organizations to focus on what matters most: bringing life-enhancing therapies to patients faster.

We're a fast-growing, mission-driven partner to the life sciences industry, delivering end-to-end compliance, validation, and technology solutions. From facility design to continuousmonitoring, our expertise keeps our clients ahead of regulatory expectations and at the forefront of innovation.

**Our Vision: Become the nation's premier single-source biopharma solution provider

Our Mission: Support those on the quest for a cure

About the Role**

We're looking for a CQV Engineer who thrives in dynamic environments and enjoys taking their expertise directly to the field. This role blends technical rigor with real-world impact-working onsite with clients to bring critical systems online, ensure compliance, and enable production of life-saving products.

If you enjoy travel, problem-solving, and hands-on validation work, this role will keep you challenged and engaged.

**What You'll Do**

Lead Validation & Commissioning Efforts

• Develop, review, and execute CQV documentation for facilities, equipment, and utilities
• Author validation lifecycle documents: URS, FS/DS, IQ/OQ/PQ, TMX, VSRs
• Translate system requirements into actionable, testable validation protocols

Be Hands-On in the Field

• Commission and qualify utilities, infrastructure, and HVAC systems
• Execute protocols and perform field verification at client sites
• Perform performance checks and troubleshoot system issues in real time

Ensure Compliance & Quality

• Lead and support GxP and risk assessments
• Author and review SOPs, periodic reviews, and validation reports
• Ensure all work aligns with cGMP and regulatory expectations

Collaborate & Innovate

• Partner with clients and cross-functional teams to deliver practical solutions
• Support validation teams and provide guidance during protocol execution
• Contribute to continuous improvement and smarter compliance strategies

**What Makes This Role Exciting**

• Travel & Variety - Work across multiple client sites and projects throughout the country
• Meaningful Impact - Your work directly supports the delivery of life-saving therapies
• Hands-On Engineering - Not stuck at a desk-you'll be in the action
• Growth Opportunity - Expand your expertise across systems, industries, and technologies

**What You Bring**

Education & Experience

• Bachelor's degree in Chemical Engineering, Biomedical Engineering, or related field
• 5+ years of CQV, equipment validation, process validation, or remediation experience (cGMP preferred)
• Experience in life sciences or GxP-regulated environments

Skills & Strengths

• Strong technical writing and documentation expertise
• Solid understanding of cGMP regulations and validation principles
• Excellent problem-solving and analytical skills
• Adaptable, customer-focused, and positive mindset

• **Travel Expectations**
• This role requires regular travel (local and nationwide) to support client projects. Ideal candidates are flexible and excited to work in different environments.
• **What We Offer**
• We support our team the way they support our clients-fully.

Comprehensive Benefits Package

• Medical, Dental, Vision, and Prescription Coverage
• Health Savings Account (HSA)
• Life Insurance & AD&D
• Short & Long-Term Disability

Work-Life Balance

• Unlimited Paid Time Off
• 11 Paid Company Holidays
• Employee Assistance Program

**Work Environment**

• Work in controlled environments including cleanrooms and laboratories
• Use of PPE (gowning, masks, sterile requirements)
• Physical activity including standing for extended periods and lifting up to 30 lbs

**Equal Opportunity Employer

VaLogic Bio, LLC is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Ready to Make an Impact?**

If you're passionate about engineering, compliance, and making a difference in healthcare, we want to hear from you.

Apply today and help bring the next generation of therapies to life.

VaLogic Bio, LLC (VaLogic) does not accept unsolicited resumes from search firms or any other third parties. Any unsolicited resume sent to VaLogic will be considered VaLogic property, and VaLogic will not pay a fee should it hire the subject of any unsolicited resume.

## Qualifications

**Qualifications and Skills**

• **Education and Experience**
• Bachelor’s Degree in Chemical Engineering or Biomedical Engineering from a 4-year University
• Previous experience in Life Sciences Industry is preferred
• Previous experience in GxP Industries is preferred
• Must be adaptable, customer service oriented, have a positive attitude
• 5+ years of equipment validation, process validation, and/ or remediation experience in a cGMP- preferred
• **Skills and Abilities**
• Must have strong written and verbal communication skills
• Excellent technical writing skills
• Strong analytical and problem-solving skills
• Thorough knowledge of cGMP guidelines