CSV Specialist

We are seeking a skilled Computer System Validation (CSV) Specialist to support a fully onsite project with one of our key clients. The ideal candidate will have strong experience in validating GxP-regulated systems, ensuring compliance with 21 CFR Part 11, EU Annex 11, and applicable FDA and international regulations.

Responsibilities:

• Develop, review, and execute validation deliverables including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, Traceability Matrices, Test Protocols (IQ/OQ/PQ), and Summary Reports.

• Ensure systems are validated in accordance with client and regulatory requirements.

• Support change control processes and manage deviations and CAPAs related to computer systems.

• Collaborate with QA, IT, and business stakeholders to gather requirements and maintain validation documentation.

• Conduct periodic reviews and revalidations as needed.

• Participate in audits and inspections, providing validation documentation as required.

Requirements:

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.

• 3+ years of hands-on CSV experience in regulated industries (pharmaceutical, biotechnology, or medical device preferred).

• Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles.

• Experience with validation of software systems such as MES, Data Historian, ERP, or SCADA preferred.

• Excellent written and verbal communication skills.

• Ability to work independently and onsite at client facilities.

Preferred Qualifications:

• Experience working in a highly regulated environment.

• Familiarity with validation in cloud-based and hybrid system environments.

• Knowledge of SDLC and risk-based validation approaches.