CSV Consultant

Experteer Overview In this role you will contribute to validation efforts in a regulated pharmaceutical/biotech/medical device environment. You will apply SDLC and computer system validation to ensure compliant systems, collaborating with cross-functional and remote teams. You will author, review and maintain validation deliverables, test plans, protocols and reports, and oversee test activities and traceability. You will lead or support projects across multiple changes while maintaining strong communication. This is an opportunity to drive quality and compliance in a fast-paced, regulated setting. Compensation / Benefits * Apply System Development Lifecycle (SDLC) and Computer System Validation (CSV) practices in regulated environments * Write, execute, and maintain validation deliverables (requirements, validation plans, test protocols, test summary reports, compliance reports) * Review system test scripts, UAT scripts, traceability matrices, and design specifications * Design, review, and approve QA methodologies, test plans, UAT scripts, and test procedures * Collaborate with cross-functional and remote teams; lead or work independently on multiple projects * Communicate effectively, both verbally and in writing, to ensure regulatory compliance and project progress Tasks * Ex-Pharmaceutical background preferred * Experience in Pharmaceutical, Biotechnology, or Medical Device industry * 2+ years of SDLC experience * 3+ years of Computer System Validation (CSV) experience * Familiarity with FDA and Global regulated environments; GxP standards and risk-based validation * Knowledge of FDA guidance and industry standards (GAMP) * Experience writing and executing validation deliverables and related documentation * Experience reviewing test scripts, UAT scripts, and Design Specs; experience with Traceability Matrix * QA methodologies experience; designing/reviewing/approving test plans, UAT, and test procedures * Strong verbal and written communication skills * Ability to work in a team, lead when needed, and manage multiple projects with remote teams Key requirements *

You and approve QA methodologies, test plans, UAT scripts, and test procedures * Collaborate with cross-functional and remote teams; lead or work independently on multiple projects * Communicate effectively, both verbally and in writing, to ensure regulatory compliance and project progress Tasks * Ex-Pharmaceutical background preferred * Experience in Pharmaceutical, Biotechnology, or Medical Device industry * 2+ years of SDLC experience * 3+ years of Computer System Validation (CSV) experience * Familiarity with FDA and Global regulated environments; GxP standards and risk-based validation * Knowledge of FDA guidance and industry standards (GAMP) * Experience writing and executing validation deliverables and related documentation * Experience reviewing test scripts, UAT scripts, and Design Specs; experience with Traceability Matrix * QA methodologies experience; designing/reviewing/approving test plans, UAT, and test procedures * Strong verbal and written communication skills * Ability to work in a team, lead when needed, and manage multiple projects with remote teams Key requirements *