(Contract) Associate CQV Engineer
Description
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.
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.
Educational Background:
The ideal candidate will have a bachelor’s degree in a science-related field such as Biomedical Engineering, Mechanical Engineering or Chemical Engineering.
Experience:
- 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 guidelinesExperience with electronic documentation and quality management systems
- Excellent technical writing, organization, and communication skills
Desired Aptitude and Skill Set:
- 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)
Travel:
Up to 50% travel is possible for onsite client CQV support
Compensation:
Hourly rate is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions
About Kymanox:
Join Kymanox – a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.
Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC.
To learn more about our company, please visit our website: Life Science Solutions | Kymanox
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.