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)

Compensation:

The current salary range for this role is estimated to be $91,000-121,000. 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.

What We Offer:

• 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.

What You’ll Do:

• 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.

Pharmaceutical regulatory compliance and governance

• 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.

Risk-based validation lifecycle

• 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.

Validated state, data integrity and lifecycle assurance

• 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.

Partnership and capability building

• 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

What You’ll Need:

Education:

• Master's degree (or equivalent Bac+5) in Life Sciences, Pharmacy, Engineering, Computer Science, Quality, or a related discipline.

Required Experience:

• 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.
• Experience supporting audits, regulatory inspections, and remediation activities is strongly preferred.

Preferred Experience:

• 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.
• Familiarity with automated testing tools and digital validation or requirements management platforms is considered an asset.

Work Environment

• Primarily office-based role supporting global operations.
• Frequent interaction with Quality, Regulatory Affairs, Operations, and Digital/IT teams in a matrix environment.

Physical Demands

• While performing the duties of this position, the employee is regularly required to sit, talk, hear, and use hands and fingers to operate a computer and other office equipment.
• The employee is occasionally required to stand, walk, bend, reach, and lift or move items weighing up to 15 pounds.

Position Type/Expected Hours of Work

• This is a full-time position.
• Days and flexible hours of work may be required to meet demands of global collaboration.

Business Travel:

• Occasional domestic or international travel to Roquette sites, suppliers or professional events.

AAP/EEO Statement

Roquette is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law. “AAP, EEO, Drug-Free Workplace”

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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