Validations officer

12 Month Contract
The Contract Validation Officer’s main responsibility will be to assist the Commissioning & Qualification (C&Q) Technician from Cape Town and the Project Engineer at East London to perform periodic reviews of all facilities, utilities, systems, and equipment in accordance with cGMP, regulatory requirements, and Kenvue Global Standards.
The role must be capable to support the entire project lifecycle—from URS through PQ and release—ensuring that project deliverables and ongoing validation activities are completed on time, compliant, and embedded within the Engineering Validation Master Plan (EVMP).
The Contract Validation Officer works cross‑functionally with Project Managers, Engineering, Maintenance, Facilities, Quality Assurance, and external vendors to ensure allocated systems are validated, maintained in a validated state, and meet regulatory requirements

Job purpose
The Contract Validation Officer’s main responsibility will be to assist the Commissioning & Qualification (C&Q) Technician from Cape Town and the Project Engineer at East London to perform periodic reviews of all facilities, utilities, systems, and equipment in accordance with cGMP, regulatory requirements, and Kenvue Global Standards.
The role must be capable to support the entire project lifecycle—from URS through PQ and release—ensuring that project deliverables and ongoing validation activities are completed on time, compliant, and embedded within the Engineering Validation Master Plan (EVMP).
The Contract Validation Officer works cross‑functionally with Project Managers, Engineering, Maintenance, Facilities, Quality Assurance, and external vendors to ensure allocated systems are validated, maintained in a validated state, and meet regulatory requirements.

• Periodic Reviews
  • Ensure all allocated periodic reviews (PRs) are initiated, completed, and approved within mandated due dates.
  • Collaborate with Maintenance and Facilities teams to gather necessary data and align findings with requirements.
• Audit Trail Reviews
  • Ensure all allocated audit trail reviews are initiated, completed, and approved within mandated due dates.
  • Review audit trail review reports.
• Re‑Qualification
  • Execute re‑qualification activities per Kenvue global SOPs.
• Decommissioning
  • Support Engineering and Facilities in the controlled decommissioning of identified equipment.
  • Ensure proper documentation, risk assessments, and regulatory compliance during removal from service.

Work closely with Project Managers and Engineering to execute all C&Q lifecycle elements, ensuring documentation, testing, and approvals are completed on time.

• Requirements Definition
  • User Requirement Specification (URS) development, review, and approval.
• Specification & Design Controls
  • Critical Aspect Risk Assessment (CARA)
  • Critical Aspect Design Review (CADR)
  • System Test Matrix (STM)
  • Design Qualification (DQ)
  • Project Qualification Plan (PQP)
• Commissioning Activities
  • Factory Acceptance Tests (FAT)
  • Site Acceptance Tests (SAT)
  • Mechanical Completion verification
• Qualification Execution
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
• Finalization & Release
  • Compilation of Qualification Summary Report (QSR)
  • Participation in final review and acceptance meetings
  • Formal release of equipment or system for operational use

• Execute CSV deliverables including risk assessments, functional testing, security/access reviews, and audit trail assessments.
• Ensure alignment with 21 CFR Part 11 and EU Annex 11 requirements.
• Maintain validated-state documentation for all computerized systems…