CSV - Expert

Topia LifeSciences is a forward-thinking organization committed to delivering high-quality solutions to the life sciences industry. We strive to ensure regulatory compliance, operational excellence, and innovation across pharmaceutical, biotech, and medical device sectors. As we continue to grow, we are seeking a skilled Computer System Validation (CSV) Expert to join our quality team and support our expanding portfolio of regulated systems.

Role Summary

As a CSV Expert at Topia LifeSciences, you will be responsible for ensuring that all computerized systems used within GxP environments are validated according to applicable regulatory standards and internal procedures. You will work cross-functionally with QA, IT, engineering, and operations teams to ensure data integrity, regulatory compliance, and audit readiness.

Key Responsibilities

• Lead and execute full lifecycle validation activities for GxP-regulated systems (e.g., LIMS, ERP, MES, QMS, lab instruments).

• Prepare and review CSV documentation including:

o Validation Plans (VP)

o User Requirements Specifications (URS)

o Functional Specifications (FS)

o Risk Assessments

o IQ/OQ/PQ Protocols and Reports

o Traceability Matrices

o Validation Summary Reports

• Ensure compliance with global regulatory requirements including:

o 21 CFR Part 11

o EU Annex 11

o ICH Q9/Q10

o GAMP 5

o Data Integrity Guidelines (ALCOA+)

• Collaborate with IT, QA, engineering, and business stakeholders for system implementation, upgrades, and revalidations.

• Support audit readiness and participate in regulatory and client audits.

• Conduct gap assessments of existing systems and recommend validation strategies.

• Provide SME support on deviation investigations, CAPAs, and change controls.

• Maintain validation status across system lifecycle and ensure timely periodic reviews.

• Train cross-functional teams on CSV processes and regulatory expectations.

Qualifications

Education:

• Bachelor’s or Master’s Degree in Engineering, Computer Science, Life Sciences, or related field.

Experience:

• 5+ years of relevant experience in Computer System Validation in a regulated (GxP) environment.

• Proven experience validating a variety of systems such as:

o LIMS, MES, ERP, QMS, SCADA, Lab Instruments, eQMS

• Experience with cloud-based solutions and SaaS platforms is a plus.

Knowledge & Skills:

• Strong understanding of GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity guidelines.

• Excellent technical writing and documentation skills.

• Ability to manage multiple projects and work in cross-functional teams.

• Familiarity with validation management tools and electronic documentation systems