Kymanox · 12 hours ago
(Contract) CQV Engineer - Project Based
Wilmington, NC
Contract
Onsite
Entry, Mid Level
1+ years expKymanox is a life sciences professional services company dedicated to helping get modern medicines to market. The (Contract) CQV Engineer will support various technical projects related to commissioning, qualification, and validation within the life sciences industry.
Life ScienceTechnical Support
Responsibilities
Supporting executing a variety of technical projects and/or programs
Define, develop, and execute the validation lifecycle following GAMP5® principles – including requirement specifications and qualification protocols (e.g., URS, FRS, DDS, DR, IQ, OQ, PQ, TM) in support of Commissioning & Qualification (C&Q) activities
Collaborating with Engineering and Quality professionals
Commissioning and Qualification of GMP facilities, utilities, and equipment
Provide technical project leadership and contributions to CQV projects, including managing schedules, support staff, and project execution
Provide review and input on areas of subject matter expertise
Review and summarize data for presentation to quality and regulatory professionals
Qualification
Required
Direct experience in Commissioning, Qualification or Validation
Bachelor's degree in a science-related field such as Biomedical Engineering, Mechanical Engineering or Chemical Engineering
1-3 years of experience in the Biotechnology, Pharmaceutical, and/or Medical Device industries working in one (1) or more of the following departments: Validation, Manufacturing, Process Engineering, Technical Services, or Manufacturing Sciences, Quality Control or Quality Assurance, Process Development
Experience in Life Science industry performing IOQ on automated equipment
Leading and executing a variety of technical projects and/or programs
Collaborating with highly skilled professionals
Commissioning, start-up, and qualification of GMP facilities, utilities, or equipment
Working with quality and regulatory professionals
Proven ability to develop validation strategy independently
Detail-oriented
Highly organized
Managerial or leadership skills
Excellent written and oral English communication skills
Understanding of own limitations
Fast learner
Ability to motivate self and others
High energy level
Excellent problem-solving skills
Seasoned soft skills
Team player
IT and technology savvy
Understanding of FDA's CGMPs
Preferred
Experience in Validation
Experience with CSV
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