Engineer, Computer Software Assurance

Accountabilities •

Lead the development and execution of comprehensive Computer System Validation (CSV) and Computer Software Assurance (CSA) strategies, plans, and protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

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Oversee validation activities for GxP-regulated computerized systems, including enterprise resource planning (ERP) platforms, quality management systems (QMS), manufacturing execution systems (MES), manufacturing equipment software, data integrity systems, and custom applications.

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Ensure computerized systems comply with applicable regulatory requirements, including FDA 21 CFR Part 820, 21 CFR Part 11, ISO 13485, and other relevant global standards.

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Develop, review, and maintain validation documentation, including User Requirements Specifications (URS), design specifications, validation plans, traceability matrices, qualification protocols, summary reports, and controlled procedures.

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Apply risk-based validation methodologies to assess system functionality, identify compliance gaps, and establish appropriate verification and testing strategies.

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Ensure data integrity, electronic records, electronic signatures, audit trails, and system security controls meet regulatory and organizational requirements.

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Collaborate with IT, Quality Assurance, Engineering, Manufacturing, and other stakeholders to support compliant system implementations, upgrades, and lifecycle management.

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Provide technical guidance on validation best practices and contribute to the development and improvement of CSV, CSA, and quality management processes.

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Support regulatory inspections and audits by preparing validation documentation, addressing findings, and providing subject matter expertise when required.

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Stay informed about evolving regulatory expectations, validation methodologies, and emerging technologies to improve compliance and operational efficiency.

Requirements

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At least 5 years of experience in Computer System Validation within a regulated medical device, pharmaceutical, biotechnology, or comparable life sciences environment is preferred.

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Advanced knowledge of FDA 21 CFR Part 11, 21 CFR Part 820, ISO 13485, ISO 14971, GAMP 5 guidelines, and FDA guidance on risk-based software validation and Computer Software Assurance.

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Demonstrated experience leading the planning, execution, and documentation of validation activities for enterprise and manufacturing systems.

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Proven ability to develop and maintain comprehensive validation documentation, including URS, design specifications, traceability matrices, validation plans, IQ/OQ/PQ protocols, summary reports, and standard operating procedures.

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Strong understanding of data integrity principles, audit trails, electronic records and signatures, and computerized system security.

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Excellent analytical, problem-solving, technical writing, and communication skills, with the ability to explain complex technical and regulatory concepts clearly.

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Strong organizational skills and the ability to manage multiple validation activities while maintaining accuracy, documentation quality, and regulatory compliance.

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Ability and willingness to travel as required.

Preferred qualifications:

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Familiarity with EU Medical Device Regulation (EU MDR), EU GMP Annex 11, and ISO 27001 information security standards.

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Hands-on experience validating cloud-based platforms and Software-as-a-Service (SaaS) applications.

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Experience supporting FDA inspections and Notified Body audits as a Computer System Validation subject matter expert.

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Experience developing, standardizing, or improving CSV, CSA, and Quality Management System processes.

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Ability to collaborate effectively with global teams and contribute to continuous improvement initiatives in regulated environments.

Benefits

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Competitive benefits package designed to support employee health, financial well-being, and work-life balance.

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Healthcare benefits and additional employee support programs, subject to location-specific policies.

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Paid time off to support personal needs and well-being.

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Potential remote-work flexibility , with the specific arrangement to be confirmed during recruitment.

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Professional development opportunities in computer software assurance, regulatory compliance, and validation of modern enterprise and manufacturing technologies.

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Cross-functional collaboration with experienced professionals in quality, engineering, IT, and manufacturing.

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Meaningful professional impact through work that supports the quality, safety, and reliability of technologies used in healthcare.

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Continuous improvement culture that encourages innovation, technical growth, and the adoption of effective validation practices.

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