(Contract) CQV Engineer

Kymanox • Charlottesville, VA

4d

About The Position

Is Kymanox the right fit for you? You want to make a difference and have an impact… You enjoy having an influence in your day-to-day work… You are motivated by working alongside a team filled with subject matter experts who will help you learn and grow… You wake up every day and do what you do … because patients deserve better. If this sounds like you, you’ve come to the right place. The (Contract) CQV Engineer will have direct experience in Commissioning, Qualification or Validation.

Requirements

• 5 years of hands-on CQV experience in pharmaceutical, biotechnology, and/or medical device industries
• Direct experience executing IOQ/PQ on automated equipment (filling lines, isolators, lyophilizers, device assembly equipment strongly preferred)
• Proven ability to author and execute qualification protocols independently
• Strong working knowledge of cGMP (21 CFR 210/211, Part 11, EU Annex 11), ASTM E2500, GAMP 5, and ISPE guidelinesExperience with electronic documentation and quality management systems
• Excellent technical writing, organization, and communication skills
• The ideal candidate will have a bachelor’s degree in a science-related field such as Biomedical Engineering, Mechanical Engineering or Chemical Engineering.

Nice To Haves

• Proven ability to develop validation strategy independently
• Detail-oriented
• Highly organized
• Excellent written and oral English communication skills
• Excellent problem-solving skills
• Seasoned soft skills
• Team player
• IT and technology savvy
• Understanding of FDA’s CGMPs (i.e., Quality Systems)

Responsibilities

• Author, execute, and summarize commissioning and qualification deliverables including FAT/SAT, IQ, OQ, PQ protocols and reports for process equipment, clean utilities (WFI, clean steam, gases), HVAC/cleanrooms, and automated systems.
• Apply risk-based CQV approach in accordance with ASTM E2500, ICH Q9, and ISPE Baseline Guides.
• Perform field execution: system walkdowns, punch-list resolution, functional testing, loop checks, and startup support.
• Generate, investigate, and resolve deviations; support change control and CAPA processes in electronic quality systems.
• Author traceability matrices linking URS → critical aspects → testing.
• Collaborate daily with Engineering, Quality, Automation, Manufacturing, and client stakeholders.
• Provide technical input during design reviews and risk assessments (FMEA, PHA).
• Support validation maintenance activities (periodic review, re-qualification, change control impact assessments).
• Lead small to medium subsystems or work packages under guidance of a senior CQV lead.

What This Job Offers

• Career Level: Mid Level
• Number of Employees: 251-500 employees