Computerized System Validation Specialist

Roquette•Newark, NJ

5d•Onsite

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 ensuring GxP computerized systems remain 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 based 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 embeds quality and compliance from project initiation through implementation, operation, change, periodic review, and retirement; interprets applicable regulations and guidance; and supports regulatory readiness, remediation, and continuous improvement. It also builds capability by coaching and training system owners, process owners, project teams, and key users. This is a primarily office-based role supporting global operations, with frequent interaction across Quality, Regulatory Affairs, Operations, and Digital/IT in a matrix environment. Occasional domestic or international travel to Roquette sites, suppliers, or professional events may be required. Days and flexible hours may be needed to support global collaboration. The current estimated salary range is $91,000–$121,000. The position may also be eligible for performance-based incentive compensation. Compensation is influenced by factors including skills, qualifications, experience, internal equity, and location.

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.
Days and flexible hours of work may be required to meet the demands of global collaboration.
Ability to meet the stated physical demands, including operating a computer and office equipment and occasionally 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.
Understanding of cloud and SaaS solutions, IT infrastructure, cybersecurity considerations, and supplier/service-provider operating models.
Familiarity with automated testing tools and digital validation or requirements management platforms.

Responsibilities

Own and apply the risk-based Computerized Systems Validation framework for GxP applications, platforms, infrastructure, and digital solutions across Roquette.
Ensure compliance with applicable pharmaceutical requirements and recognized 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 system project and lifecycle activities, from initiation and implementation through operation, change, periodic review, and retirement.
Monitor regulatory developments and translate new or revised expectations into standards, procedures, controls, and remediation plans.
Promote scalable, risk-based validation approaches suited to Agile, SaaS, cloud, and modern digital delivery models.
Interpret GxP regulations and expectations for computerized systems and electronic records and support consistent implementation.
Contribute to and maintain the Validation Master Plan, CSV policies, standards, procedures, templates, system inventory, and GxP classifications.
Perform regulatory impact assessments and support gap assessments, remediation programs, and inspection readiness.
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 final validation reports 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 defined.
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 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.

Benefits

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 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
Tuition reimbursement program for select roles
Annual wellness benefit
Wellness-centered programs focused on employee health needs