Validation SME

Develop and maintain validation plans, protocols, reports and SOPs. Ensure validation activities meet GMP and regulatory requirements. Prepare risk assessments, technical justifications and validation documentation. Conduct and support equipment qualification, smoke studies and APS. Identify and manage validation risks, deviations, CAPAs and change controls. Assess validation requirements for equipment, engineering and process changes. Support revalidation and lifecycle management of equipment and systems. Resolve basic equipment issues and escalate complex faults when required. Drive process improvements, efficiency and cost-saving initiatives. Provide technical support to Validation and cross-functional teams. Critical Requirement: Strong experience in sterile pharmaceutical manufacturing and validation is essential, including hands-on experience with equipment qualification, APS and smoke studies. Qualification: Grade 12/Matric & Degree in Life Sciences, Chemistry, Pharmacy or Engineering (Post-Graduate qualification is advantageous) Experience: 8 - 10 Years’ sterile pharmaceutical manufacturing experience & minimum of 5 Years’ validation experience Regulatory inspection experience Strong technical and scientific writing and investigation skills