Computer Systems Validation Engineer

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Overview

Tentamus North America is searching for a skilled Computer Systems Validation Engineer to lead validation efforts, strengthen regulatory compliance, and support the implementation of high‑quality, risk‑based IT and laboratory systems. This role is ideal for someone with deep knowledge of cGMP, a strong analytical mindset, and the ability to translate complex technical requirements into compliant, reliable solutions.

What You’ll Do as the CSV Engineer

The CSV Engineer performs validation services, including but not limited to equipment qualification, method validation, protocol generation and execution, data analysis and reporting; generating, executing, and reviewing validation protocols and reports for equipment, instruments, utilities, and control systems through the Commissioning, ERES, VP, FDS, DS, URS, IQ, OQ, PQ, and VSR phases.

Validation Documentation & Execution

• Author, review, approve, and execute validation documentation, including protocols, summary reports, procedures, and other lifecycle documents.
• Design, implement, and support validation strategies and protocols for products, raw materials, and development projects.
• Provide URS, validation plans, and risk assessments for new systems and equipment introduced to the facility.
• Provide technical support for validation activities associated with Quality Control testing processes.

Compliance, cGMP, and Quality Assurance

• Ensure validation studies and related activities comply with cGMP, quality systems, and IT Quality Assurance practices.
• Participate in and support internal and external audits and inspections, including identifying compliance gaps and implementing corrective actions.
• Assess site regulatory compliance status and ensure implementation of CAPA for ongoing inspection readiness.
• Identify, communicate, and manage trends in operational compliance risks, ensuring appropriate CAPA is agreed upon with stakeholders.
• Provide compliance input for internal management reviews and external regulatory inspections.
• Develop and implement quality standards, including SOPs and processes for IT products and services.

Validation Support & Troubleshooting

• Support and maintain the validation department’s equipment inventory.
• Generate data and reports for validation system evaluation programs.
• Investigate and conduct troubleshooting and root‑cause analysis for validation‑related incidents and deviations.
• Resolve CAPAs and non‑conformances related to validation activities.

Cross‑Functional Collaboration & Representation

• Partner with Quality Laboratories, QA, and cross‑functional teams on validation study execution and quality initiatives.
• Represent equipment qualification and validation programs during client and regulatory audits.
• Utilize compliance expertise to guide program, project, and system owners in applying a risk‑based approach to compliant IT solution delivery.

Continuous Improvement & Digitalization

• Drive continuous monitoring, improvement, and digitalization of processes, services, and tools by applying Lean methodologies and automation.

Skills & Technical Competencies

• Demonstrate in-depth knowledge of cGMP regulations, quality systems, and IT Quality Assurance practices.
• Maintain strong organizational, documentation, analytical, and problem‑solving abilities.
• Be proficient in using Quality Management software and tools.
• Work collaboratively with cross‑functional teams to achieve quality and compliance objectives.

Schedule & Position

This is a full‑time, Monday‑Friday hybrid position. Occasional evening and weekend work may be required for performance tests or software rollouts, and domestic travel up to 20% may be necessary for project implementation and collaboration. This role primarily operates in an office environment but offers flexibility for remote work based on organizational needs. Collaboration with multiple departments and teams is essential.

Qualifications

• Authorized to work in the United States indefinitely without restrictions or sponsorship.
• Bachelor’s Degree in Chemistry, Laboratory Sciences, Computer Science, or a related field preferred;…