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Job Summary
Are you passionate about contributing to global health and vaccine innovation? Afrigen Biologics is seeking a qualified and experienced Validation Engineer to support all aspects of validation, including developing testing protocols, supporting primary field execution activities, and developing validation reports.
This role involves supporting the implementation of the Validation Lifecycle and Validation Master Plan.
Key Responsibilities:
- Develop and execute validation protocols (DQ/IQ/OQ/PQ) for process, equipment, facility, utilities, and related software.
- Generate validation reports to summarise test results and ensure compliance with regulatory and cGMP requirements.
- Review and approve User Requirement Specifications, Functional Specifications and supplier documentation.
- Support validation lifecycle management, including the development of the Validation Master Plan (VMP).
- Perform equipment, process, facility, and utility qualification/re-qualification to ensure compliance with site quality standards.
- Oversee validation execution with suppliers, operators, and maintenance teams, which may include Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).
- Ensure validation documentation accuracy and completion, including coordinating approvals and supporting audits.
- Collaborate with QC, production and maintenance teams to support new equipment installation, Performance Qualification (PQ), and Cleaning Validation (CV).
- Contribute to continuous improvement efforts by harmonizing and streamlining validation activities.
Qualifications and Experience:
- National Diploma, BTech or Bachelor’s degree in Engineering, or a related field.
- At least 5 years’ experience within the Validation field.
- A good understanding of cGMP and South African regulatory environment is a must.
- Excellent communication and interpersonal skills
Afrigen Biologics & Vaccines
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