Computerized System Validation Specialist

We are looking for our next Computerized System Validation Specialist within our Quality Management Systems Team. The CSV Specialist is responsible for safeguarding patient safety, product quality, and data integrity by ensuring GxP computerized systems remain compliant throughout their lifecycle. This role 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.

This position is located in Newark, Delaware
, United States (Newark, DE, US) or Midland, Michigan
, United States (Midland, MI, US)

The current salary range for this role is estimated to be $91,. In addition, this position may be eligible to earn performance-based incentive compensation. The specific compensation offered to a candidate will be influenced by a variety of factors including but not limited to skills, qualifications, experience, internal equity, and role location.

• A highly collaborative team environment with ample room for exponential career growth.
• Competitive pay, annual performance bonus, comprehensive benefits, 6.2% company retirement contribution, and professional development opportunities.
• Generous paid time off and 12 annual paid company holidays.
• 12 weeks 100% paid maternity leave, and up to 4 weeks 100% paid parental leave (including adoption/surrogacy/foster care leave) for non-birthing parents.
• Student loan repayment assistance and tuition reimbursement program for select roles.
• Annual wellness benefit and wellness centered programs focused on your health needs.

• 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 applicable pharmaceutical requirements and recognized industry guidance, including EU GMP Annex 11 and Annex 15, FDA 21 CFR Part 11, GAMP 5, data integrity principles and relevant internal procedures.
• Embed quality and compliance requirements from project initiation through implementation, operation, change, periodic review and retirement.
• Maintain regulatory watch for computerized systems and translate new or revised expectations into practical standards, procedures, controls and remediation plans.
• Promote efficient, scalable and risk-based validation practices adapted to Agile, SaaS, cloud and modern digital delivery models.

• Interpret applicable GxP regulations and regulatory expectations for computerized systems and electronic records, and ensure their consistent implementation.
• Contribute to and maintain the Validation Master Plan, CSV policies, standards, procedures, templates and system inventory / GxP classification.
• Perform regulatory impact assessments and support gap assessments, remediation programs and inspection readiness activities.
• Act as the CSV subject-matter expert during internal audits, customer audits and Health Authority inspections; prepare evidence and responses within the role scope.

• Assess GxP impact, data criticality and patient / product / compliance risks; define a proportionate validation strategy and Validation Plan.
• 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 / 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 / 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…