Job Description:

Catalyx is seeking an experienced CSVQA Engineer with extensive knowledge in the Life Sciences Services industry for a customer in New Jersey.Who We Are:Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes"”globally"”with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx's partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit Role:Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organizations, to empower them to enhance efficiency, and drive success. As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations.The ideal candidate will have 5+ years hands-on experience in the life sciences industry.Required Experience and Skills: Working in a PharmaceuticalBiotechnology industry; experience working in a health authority regulated (e.g. GxP) environment.8 years of industry experience including computer system validation, System Life Cycle (SLC), software validation, andor Quality Assurance functions.Level of expertise and exposure with agency regulations, such as 21 CFR Part 11, Part 58, Part 210, Part 211 from the US Food and Drug Administration.Level of expertise in SLC methodology (e.g., V-model, waterfall, agile, spiral) including change management.Experience providing oversight for adherence to enterprise SLC and procedures.Skills dealing with and understanding typical laboratory facilities and equipment.To prioritize and manage multiple initiatives, projects terpersonal skills including ability to work as a team member in a collaborative environment.written and communication skills including thorough knowledge of Good Documentation Practices.Excellent time management skills.Attention to detail.Preferred Experience and Skills:With calibration and qualification.With configuration management.Published regulatory agency data integrity guidance.Level of experience with electronic tools such as software providing document management and testing capabilities.