Validations officer

About the position

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.

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

Commissioning & Qualification of New Facilities, Utilities & Equipment
Work closely with Project Managers and Engineering to execute all C&Q lifecycle elements, ensuring documentation, testing, and approvals are completed on time.
 
Key lifecycle phases include:
·       Requirements Definition
o    User Requirement Specification (URS) development, review, and approval.
·       Specification & Design Controls
o    Critical Aspect Risk Assessment (CARA)
o    Critical Aspect Design Review (CADR)
o    System Test Matrix (STM)
o    Design Qualification (DQ)
o    Project Qualification Plan (PQP)
·       Commissioning Activities
o    Factory Acceptance Tests (FAT)
o    Site Acceptance Tests (SAT)
o    Mechanical Completion verification
·       Qualification Execution
o    Installation Qualification (IQ)
o    Operational Qualification (OQ)
o    Performance Qualification (PQ)
·       Finalization & Release
o    Compilation of Qualification Summary Report (QSR)
o    Participation in final review and acceptance meetings
o    Formal release of equipment or system for operational use
Computer System Validation (CSV)
·       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 associated with facilities, utilities, and equipment.
Cross-Functional & General Responsibilities
·       Liaise effectively with internal departments, vendors, consultants, regulatory bodies, and contractors.
·       Manage workload to ensure timely completion of validation tasks—escalating resource or timing conflicts early.
·       Assess the impact of unplanned activities (breakdowns, urgent re-qualifications, project delays) and communicate risks to the EVMP and compliance status to the Manager.
·       Support risk assessments, deviations, investigations, change controls, and CAPA implementation related to equipment and system validation.
 
Job Requirements
Essential knowledge and skills/Qualification:
Education

• Bachelor’s degree or equivalent qualification in Engineering, Life Sciences, or a related technical discipline.

Experience

• 2–4 years of validation or qualification experience in a Pharmaceutical or FMCG manufacturing environment.
• Demonstrated familiarity with cGMP, cGEP, cGDP, and regulated industry expectations.

 
Skills & Competencies

• High attention to detail and strong documentation accuracy.
• Solid understanding of Quality Risk Management tools (FMEA, HAZOP, etc.).
• Working knowledge of quality systems (deviations, investigations, CAPA, change control).
• Ability to author, execute, and report qualification protocols.
• Competence using computerized systems (e.g., CMMS, MS Office).
• Ability to manage multiple tasks under tight timelines in a regulatory environment.

Behavioral Competencies Requirements

• Strong communication, stakeholder engagement, and interpersonal skills.
• Assertiveness, teamwork, and willingness to collaborate and provide feedback.
• Ability to manage multiple tasks under tight timelines in a regulatory environment.
• Analytical mindset with a structured approach to problem-solving.

Location and Mobility

• Position will be based at the Cape Town Facility
• Tasks/hours will be split 50/50% between Cape Town and East London
• Limited travelling to East London might be required

Desired Skills:

• Attention to detail
• Risk management
• knowledge of quality systems
• Ability to author
• CCMS systems
• ms office