Kymanox · 4 weeks ago
(Contract) Associate CQV Engineer
Kenosha, Wisconsin
Full-time, Contract
Onsite
New Grad, Entry Level
0+ years expKymanox is a life sciences professional services company dedicated to delivering high-quality projects in the biotechnology, pharmaceutical, and medical device industries. The Associate CQV Engineer will be responsible for authoring and executing commissioning and qualification deliverables, collaborating with various stakeholders, and supporting validation maintenance activities.
Life ScienceTechnical Support
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
Qualification
Required
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
Preferred
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)
Company
Kymanox
Kymanox is a technical products & project management company provides engineering, scientific, regulatory, and process operations support.
201-500 employees
H1B Sponsorship
Kymanox has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (1)
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
unknown2021-08-23Debt Financing
2021-08-02Series Unknown
Leadership Team
Stephen M. Perry
CEO
Nicholas Ciccarelli
Chief Technology Officer
Recent News
EIN Presswire
2025-05-08
GlobeNewswire News Room
2024-11-29
Company data provided by crunchbase