{"id":3438079,"url":"https://alion.io/job/ilb-consulting-services-csa-consultantsenior-validation-engineer","title":"CSA Consultant/Senior Validation Engineer","company":{"id":4484256,"name":"ilb Consulting Services","domain":"ilbenterprises.com","url":"https://alion.io/company/ilb-consulting-services","size_band":"11-50","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"JazzHR","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"contractor","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":["United 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Reports\n Review and approve lifecycle documentation, including URS, specifications, test plans, and test summaries, in alignment with ALCOA+ and Good Documentation Practices\n Oversee validation readiness and ensure prerequisites are met before formal testing\n Support change control, configuration management, and release activities\n Partner with Quality, System Owners, and Business Process Owners to ensure ongoing compliance\n Provide guidance on CSA-based, risk-driven validation approaches\n Conduct periodic system compliance reviews, validation health checks, and lifecycle assessments\n Support user access reviews, audit trail assessments, data integrity evaluations, and system inventory maintenance\n Assess compliance impacts of deviations, incidents, CAPAs, and system issues, ensuring appropriate remediation and documentation\n Review and support vendor documentation, supplier assessments, and SaaS provider quality documentation\n Monitor regulatory inspection observations, internal audit findings, and compliance trends to identify process improvements\n Participate in governance forums and compliance review boards, providing CSA guidance for system lifecycle management and operational support\nRequirements:\n 5-8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains\n Strong understanding of CSA principles, CSV, and SDLC processes\n Experience authoring and/or reviewing validation documentation\n Working knowledge of GxP regulations, including FDA, EMA, and ICH, and data integrity expectations\n Ability to work independently in a fast-paced, matrixed environment\n Strong communication skills and comfort interacting with Quality and business stakeholders\n Preferred: experience with enterprise platforms supporting PV, Clinical, or Regulatory operations\n Preferred: prior role as a Validation SME, CSA Lead, or Compliance Consultant\n Preferred: familiarity with electronic quality systems, change management tools, or application lifecycle management platforms\nBenefits:\n Contracted employment\n C2C or W2 engagement options","description_format":"text","description_chars":2477,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-29T04:01:54Z"}],"visa":[],"liveness":{"score":81,"band":"hot","label":"Hiring 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