Data Validation Lead (CSV | GxP Systems)

MVG Recruitment; Cape Town; On-site; ZAR 900,000 - 1,200,000; Full time

Job summary

MVG Recruitment is seeking a Data Validation Lead to oversee site-wide CSV and Data Integrity activities for a pharmaceutical manufacturing site in Cape Town. You will drive validation readiness and ensure systems remain compliant, validated, and secure.

Reporting to the Validation Manager, you will collaborate with Quality, Manufacturing, QC, Regulatory Affairs and IT to maintain data integrity and support inspections and CAPAs throughout the product lifecycle.

Qualifications

• 3–5 years in pharmaceutical validation (CSV, Data Integrity or Quality Systems) in a regulated setting.
• Experience validating computerized systems such as LIMS, EDMS or other GxP platforms.
• Strong knowledge of FDA 21 CFR Part 11, Annex 11, GMP, and Data Validation principles.

Responsibilities

• Lead site-wide CSV and Data Validation initiatives across regulated GxP systems.
• Develop, implement, and maintain CSV strategies, policies, and procedures.
• Support audits, inspections, CAPAs, deviations, and change controls.
• Partner with Quality, Manufacturing, QC, Regulatory Affairs, and IT to ensure ongoing compliance.

Skills

CSV validation

GxP systems

Data integrity

Regulatory compliance

Stakeholder engagement

Education

Degree/Diploma in CS/IS/Engineering

Science background (Chemistry/Biology/Biotechnology/Pharmacy)

Tools

LIMS

EDMS

GxP lab systems

Job description

Position: Data Validation Lead (CSV | GxP Systems)

Location: Cape Town

Industry: Pharmaceutical Manufacturing

Department: Validations

REF: MVG/DVL

A leading pharmaceutical manufacturer is seeking a Data Validation Lead to provide site-wide support for Computer Systems Validation (CSV) and Data Integrity (DI) activities, ensuring critical systems remain compliant, validated, secure, and inspection-ready. Reporting to the Validation Manager, this role will drive compliance across laboratory, manufacturing, quality, and business systems while fostering a culture of data integrity and operational excellence.

Key Responsibilities

• Lead site-wide CSV and Data Validation initiatives across regulated GxP systems.
• Develop, implement, and maintain Data Validation and CSV strategies, policies, and procedures.
• Ensure compliance with FDA 21 CFR Part 11, Annex 11, GMP, and GAMP requirements.
• Oversee qualification and validation activities, including DQ, IQ, and OQ.
• Support audits, inspections, investigations, CAPAs, deviations, and change controls.
• Partner with Quality, Manufacturing, QC, Regulatory Affairs, and IT teams to ensure ongoing compliance and validation readiness.

Essential Requirements

• Degree or Diploma in Computer Science, Information Systems, Engineering, Automation
• Solid grounding in Chemistry, Biology, Biotechnology, Pharmacy, or a related scientific discipline.
• Min 3-5 years' experience in pharmaceutical validation, including CSV, Data Integrity, or Quality Systems within a regulated pharmaceutical or biotechnology environment.
• Strong knowledge of FDA 21 CFR Part 11, Annex 11, GAMP, GMP, and Data Validation principles.
• Experience validating computerized systems such as LIMS, EDMS, laboratory systems, and other GxP-regulated platforms.
• Strong analytical, problem-solving, investigation, and stakeholder engagement skills.

Advantageous

• Experience within sterile, aseptic, vaccine, or biotechnology manufacturing environments.
• Successful exposure to local and international regulatory inspections and audits.
• Certifications in Quality Assurance, Regulatory Affairs, Data Integrity, or Validation.
• Project management and business planning experience.

Ideal Candidate

We are looking for a technically strong CSV and GxP Systems professional who combines pharmaceutical validation expertise with a scientific foundation in Chemistry, Biology, Biotechnology, or a related discipline. The successful candidate will be comfortable influencing stakeholders across the site, driving compliance initiatives, and ensuring the integrity of data and computerized systems throughout the product lifecycle.

Closing date: 16 October 2026