Validation SME

To ensure manufacturing processes, equipment, utilities, and laboratory equipment are validated and remain compliant throughout their lifecycle.

• 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 elevate 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.

• Grade 12/Matric & Degree in Life Sciences, Chemistry, Pharmacy or Engineering (Post‑Graduate qualification is advantageous)

• 8 - 10 Years’ sterile pharmaceutical manufacturing experience & minimum of 5 Years’ validation experience
• Regulatory inspection experience
• Strong technical and scientific writing and investigation skills