CSV Engineer

Role:

Location:

Contract Type:

Key Responsibilities:

• Develop and execute remediation activities for Computer System Validation (CSV) to assess, plan, and enhance CSV processes and execution in alignment with organizational and regulatory standards.

• Develop and execute validation plans for new and existing GxP computer systems and digital solutions.

• Lead and support various SDLC and Software Verification & Validation (V&V) activities, including requirements analysis, validation planning and reporting, testing, qualification, and other deliverables required to meet CSV objectives.

• Create and maintain validation documentation such as test protocols, reports, and risk/compliance assessments.

• Conduct assessments and periodic reviews of validated systems to ensure ongoing compliance with regulatory requirements and internal procedures.

• Provide subject matter expertise (SME) in CSV to system owners and users of validated systems.

• Collaborate with Quality Assurance teams to support the development and implementation of quality improvement initiatives.

Education:

Bachelor’s degree or equivalent in Computer Science, Engineering, Life Sciences, Data Science, or a related field (advanced degrees preferred).

Experience and Skills Required:

• 4–6 years of relevant experience in Computer System Validation (CSV).

• Experience in CSV within the medical device, MedTech, or pharmaceutical industry.

• Strong understanding of 21 CFR Part 11, EU Annex 11, and other applicable regulatory requirements such as ISO 13485, FDA CSA, and MDSAP.