Validation Engineer
Posted on 2025-04-17
| Category | Engineering |
|---|---|
| Location | Cape Town Region / Cape Town City Centre |
Job Summary
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
Validation Engineer position available in Cape Town Region, Cape Town City Centre. This job position was posted by . The job has been posted on 2025-04-17 in the Engineering category
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