(Contract) Associate CQV Engineer

Kymanox • Charlottesville, VA

2d

About The Position

This posting is for a potential future role as we proactively build our talent pipeline. As new opportunities arise, we’ll review applicants and reach out to those whose experience aligns with our hiring needs Job Description: 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) Associate CQV Engineer will have direct experience in Commissioning, Qualification or Validation.

Requirements

• The ideal candidate will have a bachelor’s degree in a science-related field such as Biomedical Engineering, Mechanical Engineering or Chemical Engineering.
• 0-2 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 guidelines
• Experience with electronic documentation and quality management systems
• Excellent technical writing, organization, and communication skills

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: Entry Level
• Number of Employees: 251-500 employees