CQV Engineer
About The Position
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 continuous monitoring, 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.
Requirements
- 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
- 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
- Must have strong written and verbal communication skills
- Excellent technical writing skills
- Strong analytical and problem-solving skills
- Thorough knowledge of cGMP guidelines
Nice To Haves
- Previous experience in Life Sciences Industry is preferred
- Previous experience in GxP Industries is preferred
Responsibilities
- 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
- 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
- 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
- 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
Benefits
- Medical, Dental, Vision, and Prescription Coverage
- Health Savings Account (HSA)
- Life Insurance & AD&D
- Short & Long-Term Disability
- Unlimited Paid Time Off
- 11 Paid Company Holidays
- Employee Assistance Program
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
