computer system validation

Job Description Job Description SummaryWe are seeking a Senior Computer Systems Validation (CSV) Analyst with strong experience in GxP-regulated pharmaceutical/life sciences environments. The candidate will be responsible for planning, leading, and executing validation activities for SCADA, Rockwell FactoryTalk, PLCs, and Ignition process control systems....

Job DescriptionJob Description Job Description: In this role, you will collaborate with cross-functional teams to ensure systems meet quality standards and regulatory requirements through a risk-based approach. This position focuses on maintaining data integrity and system lifecycle management while contributing to operational efficiency. Responsibilities:...

Job DescriptionJob Description Roles & Responsibilities : 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes Authoring of URS/FS, protocols, final reports, validation...

Job DescriptionJob Description Roles & Responsibilities : 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes Authoring of URS/FS, protocols, final reports, validation...

Job DescriptionJob DescriptionAre You Ready? CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries....

Katalyst CRO in Wilmington, DE seeks a senior Computer Systems Validation (CSV) expert to ensure GxP compliance across regulated environments. The role focuses on 21 CFR Part 11/820, SOX, EU Annex 11/22, and GAMP 5, with responsibility for audit readiness, deviation/CAPA management, and SOP/policy adherence. You will author URS/FS, protocols, final reports,...

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Computer Systems Validation Analyst II based in the United States. Join a mission-driven biotechnology environment dedicated to advancing innovative treatments and improving outcomes for patients with serious diseases. As a...

Computer Systems Validation (CSV) Associate Director, US East Coast Location: Portsmouth, NH, Onsite Join Lonza as the CSV Associate Director, US East Coast, where you will provide strategic, technical, and people leadership for Computerized Systems Validation across a growing portfolio of projects and operations. This highly visible leadership role offers...

Are You Ready? CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries. Our approach is simple—we...

Empire AI in New York seeks a Computational Research Support Specialist to enable researchers to run HPC workflows and AI pipelines on shared platforms. You will resolve issues, optimize workloads, and build a robust knowledge base so users succeed on the Empire AI computing environment. Reporting to the Manager of Computational Research Support, the role...

Boston, Massachusetts/Northeast/Full TimeAre You Ready?CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical...

Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

Job DescriptionJob DescriptionPosition: Computer System Validation/QC Informatics SpecialistSalary Range: $80,000 - $120,000/yr.Location: Coventry, RI (On-site)About PharmaronPharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide...

Quality & Compliance Manager, Computer System Validation Remote, United States JOB SUMMARY The Quality & Compliance Manager, Computer System Validation manages the quality oversight and lifecycle validation of GxP computerized systems supporting CRO and laboratory operations. The role partners with Quality, IT, system owners, operational teams, and...

Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven...

Job Description Job Title: Validation Senior Specialist - Computer Systems Req Id: 1408 Posting Start Date: 7/6/26 Job Description: Join a Leader in Pharmaceutical Manufacturing — And Build What’s Next As Spokane’s Largest Manufacturing Company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical...

Job Description Responsible for the computerized system validation and data integrity at the JHS-Spokane site. The job functions include periodic review and audit trail reviews. Drafting, reviewing, and executing equipment-specific test plans. Drafting and reviewing user requirement specifications, risk assessments, traceability matrix, and qualification...

Quality & Compliance Manager, Computer System Validation Remote, United States JOB SUMMARY The Quality & Compliance Manager, Computer System Validation manages the quality oversight and lifecycle validation of GxP computerized systems supporting CRO and laboratory operations. The role partners with Quality, IT, system owners, operational teams, and external...

KeywordsComputer System Validation, CSV, GxP, 21 CFR part 11, Risk Based ApproachRoles and Responsibilities10+ yrs. of experience in Computer System ValidationSenior Level individual with GxP experienceAbility to lead, fully knowledgeable of Agile based System development processExhibits strong knowledge and hands-on experience in Agile concepts and applies...