Computerized System Validation Specialist

Roquette

. Own and apply the risk-based Computerized Systems Validation (CSV) framework for GxP applications, platforms, infrastructure, and digital solutions across the Roquette Group .

Posted 10/16/2026full-timeUnited StatesMid-LevelSenior💰 $91,000 - $121,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Computerized Systems Validation (CSV) within GxP environments, ensuring compliance with regulatory standards such as EU GMP and FDA guidelines. Proficient in developing validation strategies, conducting risk assessments, and maintaining quality oversight throughout the system lifecycle.

Highest-signal resume keywords

Computerized Systems Validation (CSV)GxP ComplianceValidation Lifecycle ManagementData Integrity Principles (ALCOA+)Regulatory Impact Assessments

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation Deliverable ReviewUser Requirements Specifications (URS)Risk AssessmentsValidation PlansTest ProtocolsDeviation ManagementElectronic Records ManagementAudit TrailsAccess ControlsData Migration

Soft Skills

CoachingTrainingCollaborationContinuous Improvement

Tools & Technologies

LIMSCDSERPMESEQMSLaboratory Execution Systems

Industry Keywords

EU GMP Annex 11FDA 21 CFR Part 11GAMP 5PIC/SMHRAPharmaceuticalBiotechnologyMedical DeviceRegulated EnvironmentsCloud Solutions

Tech Stack

Tools & technologies

CloudCyber SecurityERP

About the role

Key responsibilities & impact

Own and apply the risk-based Computerized Systems Validation (CSV) framework for GxP applications, platforms, infrastructure, and digital solutions across the Roquette Group
Ensure compliance with pharmaceutical requirements and guidance including EU GMP Annex 11 and Annex 15, FDA 21 CFR Part 11, GAMP 5, data integrity principles, and internal procedures
Embed quality and compliance requirements from project initiation through implementation, operation, change, periodic review, and retirement
Maintain regulatory watch and translate revised expectations into standards, procedures, controls, and remediation plans
Promote scalable, risk-based validation practices adapted to Agile, SaaS, cloud, and modern digital delivery models
Interpret GxP regulations and ensure consistent implementation for computerized systems and electronic records
Maintain the Validation Master Plan, CSV policies, standards, procedures, templates, system inventory, and GxP classification
Perform regulatory impact assessments and support gap assessments, remediation programs, and inspection readiness
Act as CSV subject-matter expert during internal audits, customer audits, and Health Authority inspections
Assess GxP impact, data criticality, and patient, product, and compliance risks; define validation strategies and plans
Review and approve validation deliverables, including requirements, specifications, supplier assessments, risk assessments, traceability, test strategies, protocols, deviations, and reports
Ensure end-to-end traceability from GxP requirements and risks to design controls, verification evidence, and acceptance criteria
Confirm validation readiness and issue or approve final validation reports and Authorization for Use before production release
Ensure controls for access management, audit trails, electronic signatures, backup/restore, business continuity, data migration, interfaces, retention, and archival
Provide quality oversight for changes, upgrades, incidents, deviations, CAPA, periodic reviews, and system retirement
Assess supplier and service-provider controls, including cloud/SaaS arrangements
Maintain CSV records, metrics, and compliance status reporting; identify trends and drive continuous improvement
Partner with Quality, business, and Digital/IT teams to integrate compliance by design
Coach and train System Owners, Process Owners, project teams, and key users on GxP, CSV, data integrity, and good documentation practices
Support harmonization, simplification, and deployment of global CSV practices and tools across sites

Requirements

What you’ll need

Master's degree (or equivalent Bac+5) in Life Sciences, Pharmacy, Engineering, Computer Science, Quality, or a related discipline
Minimum of 3-5 years' experience in Computerized Systems Validation (CSV), Quality Assurance, Digital Quality, or related disciplines within pharmaceutical, biotechnology, medical device, or other regulated GxP environments
Experience supporting implementation and lifecycle management of GxP computerized systems, including validation deliverable review and approval
Experience with validation and compliance oversight of laboratory systems such as LIMS, CDS, laboratory execution systems, and instrument-integrated systems
Advanced knowledge of GxP computerized systems validation (CSV) and ALCOA+ data integrity principles
Working knowledge of EU GMP Annex 11, Annex 15, FDA 21 CFR Part 11, and GAMP 5, with awareness of relevant PIC/S and MHRA expectations
Experience developing and reviewing validation lifecycle deliverables, including GxP assessments, supplier assessments, User Requirements Specifications (URS), risk assessments, validation plans, traceability matrices, test protocols, deviation management, and validation reports
Knowledge of electronic records and electronic signatures, audit trails, access controls, data migration, system interfaces, backup and restore processes, archival, and periodic review activities
Experience supporting ERP, LIMS, MES, eQMS, and/or laboratory and manufacturing systems in regulated environments
Understanding of cloud and SaaS solutions, IT infrastructure, cybersecurity considerations, and supplier/service-provider operating models
Days and flexible hours of work may be required to meet demands of global collaboration
Occasional domestic or international travel to Roquette sites, suppliers or professional events

Benefits

Comp & perks

Competitive pay
Annual performance bonus
Comprehensive benefits
6.2% company retirement contribution
Professional development opportunities
Generous paid time off
12 annual paid company holidays
12 weeks 100% paid maternity leave
Up to 4 weeks 100% paid parental leave, including adoption/surrogacy/foster care leave, for non-birthing parents
Student loan repayment assistance
Tuition reimbursement program for select roles
Annual wellness benefit
Wellness-centered programs focused on health needs