Scalence L.L.C. · 1 month ago
CSV Lead Engineer
Oregon City, CA
Full-time
Onsite
Senior Level
7+ years expScalence L.L.C. is seeking a highly skilled and experienced professional to join their dynamic team as a CSV Lead Engineer. This role is pivotal in ensuring the validation and compliance of computerized systems and infrastructure, requiring a strong background in IT and Software Validation.
Information Technology & Services
No H1B
Responsibilities
Collaborate closely with Product Owners, Scrum Masters, Architects, and other stakeholders
Determine validation approach and identify deliverables for GXP computerized systems
Review software documentation according to corporate SOPs and regulatory guidance
Author validation plans and reports, and review test plans and reports
Ensure compliance with corporate quality policies and standards
Provide consultancy on test-related deviations and corrective actions
Lead and author system periodic reviews and risk assessments
Support system maintenance with validated state and permanent audit readiness
Qualification
Required
Applicants must be able to work directly for Artech on W2
7 years of experience in IT and Software Validation (CSV, GAMP)
Proficiency in G Suite
Basic knowledge of SAP and MES systems and their interfacing
Strong verbal, written, and interpersonal communication skills
Ability to perform detail-oriented work with a high degree of accuracy
Preferred
Experience with project management and leading validation activities
Experience in providing consultancy for validation-related questions
Experience in system audit inspection preparation and execution
Benefits
Inclusive and diverse work environment
Opportunities for professional growth and development
Supportive team culture that values collaboration and innovation
Company
Scalence L.L.C.
In today’s dynamic and competitive market, success hinges on mastering three key areas: Data Intelligence, Business Resilience, and Digital Experience.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase