Computerized System Validation Specialist

Roquette•Plaquemine, LA

6d•$91,000 - $121,000

About The Position

Roquette is seeking a Computerized System Validation Specialist to join its Quality Management Systems Team. The role safeguards patient safety, product quality, and data integrity by keeping GxP computerized systems compliant throughout their lifecycle. It provides global quality oversight for computerized systems validation, supports regulatory compliance, and partners with business and Digital/IT teams to implement risk-based validation practices across Roquette. The position may be located in Newark or Wilmington, Delaware; Midland, Michigan; Plaquemine, Louisiana; or Institute, West Virginia. The specialist owns and applies the risk-based CSV framework for GxP applications, platforms, infrastructure, and digital solutions. The role interprets relevant pharmaceutical regulations and industry guidance, maintains validation governance and system records, assesses system and data risks, and reviews or approves lifecycle validation deliverables. It also ensures appropriate data-integrity controls and validated-state oversight across system operation, change, periodic review, and retirement. The specialist works with Quality, business, Regulatory Affairs, Operations, and Digital/IT teams in a global matrix environment; supports audits and inspections; and trains and coaches system owners, process owners, project teams, and key users. The role is primarily office-based, with occasional domestic or international travel. Flexible hours may be required to support global collaboration.

Requirements

Master's degree (or equivalent Bac+5) in Life Sciences, Pharmacy, Engineering, Computer Science, Quality, or a related discipline.
Minimum of 3–5 years of 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 review and approval of validation deliverables.
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 and ALCOA+ data-integrity principles.
Working knowledge of EU GMP Annex 11, Annex 15, FDA 21 CFR Part 11, and GAMP 5.
Experience developing and reviewing validation lifecycle deliverables, including GxP assessments, supplier assessments, URS, risk assessments, validation plans, traceability matrices, test protocols, deviation management, and validation reports.
Knowledge of electronic records and signatures, audit trails, access controls, data migration, system interfaces, backup and restore, archival, and periodic review activities.
Understanding of cloud and SaaS solutions, IT infrastructure, cybersecurity considerations, and supplier/service-provider operating models.
Ability to work with Quality, business, and Digital/IT teams in a global matrix environment; days and flexible hours may be required for global collaboration.
Ability to perform the stated physical activities, including regularly sitting, talking, hearing, and using hands and fingers to operate a computer and other office equipment; occasionally standing, walking, bending, reaching, and lifting or moving items up to 15 pounds.

Nice To Haves

Experience supporting audits, regulatory inspections, and remediation activities.
Awareness of relevant PIC/S and MHRA expectations.
Experience supporting ERP, LIMS, MES, eQMS, and/or laboratory and manufacturing systems in regulated environments.
Familiarity with automated testing tools and digital validation or requirements-management platforms.

Responsibilities

Own and apply a risk-based Computerized Systems Validation framework for GxP applications, platforms, infrastructure, and digital solutions across the Roquette Group.
Ensure computerized systems comply with applicable pharmaceutical requirements and industry 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 throughout project initiation, implementation, operation, change, periodic review, and system retirement.
Monitor regulatory developments and translate new or revised expectations into standards, procedures, controls, and remediation plans.
Promote efficient, scalable, risk-based validation practices suitable for Agile, SaaS, cloud, and modern digital delivery models.
Interpret GxP regulations and expectations for computerized systems and electronic records and ensure consistent implementation.
Contribute to and maintain the Validation Master Plan, CSV policies, standards, procedures, templates, and system inventory and GxP classification.
Perform regulatory impact assessments and support gap assessments, remediation programs, and inspection readiness activities.
Serve as the CSV subject-matter expert during internal audits, customer audits, and Health Authority inspections; prepare evidence and responses within the role's scope.
Assess GxP impact, data criticality, and patient, product, and compliance risks; define proportionate validation strategies and Validation Plans.
Review and approve, as applicable, user 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 the final validation report and Authorization for Use before production release.
Ensure appropriate controls for access management, audit trails, electronic signatures, backup and restore, business continuity, data migration, interfaces, retention, and archival.
Provide quality oversight for changes, upgrades, incidents, deviations, CAPA, periodic reviews, and system retirement to maintain the validated state.
Assess supplier and service-provider controls, including cloud and SaaS arrangements, and ensure quality and validation responsibilities are clearly defined.
Maintain accurate 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 into projects and operational processes.
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.
Travel occasionally to Roquette sites, suppliers, or professional events.

Benefits

Competitive pay and annual performance bonus.
Comprehensive benefits.
6.2% company retirement contribution.
Professional development opportunities.
Generous paid time off and 12 annual paid company holidays.
12 weeks of 100% paid maternity leave.
Up to 4 weeks of 100% paid parental leave for non-birthing parents, including adoption, surrogacy, and foster-care leave.
Student loan repayment assistance and tuition reimbursement program for select roles.
Annual wellness benefit and wellness-centered programs focused on employees' health needs.
Collaborative team environment with opportunities for career growth.