Validation SME

Aspen Pharma Group; Gqeberha; On-site; ZAR 600,000 - 900,000; Full time

Job summary

Aspen Pharma Group is seeking a seasoned Validation Specialist to lead and execute sterile manufacturing validation programs across equipment, processes and systems.

You will develop validation plans and ensure GMP compliance, support risk assessments and lifecycle management, and collaborate with cross-functional teams to drive quality, efficiency and cost-saving initiatives. The role requires hands-on qualification experience with APS and smoke studies and readiness for regulatory inspections.

Qualifications

• 8-10 years sterile pharmaceutical manufacturing experience.
• Minimum 5 years validation experience.
• Regulatory inspection experience.
• Strong technical and scientific writing and investigation skills.

Responsibilities

• 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.
• Strong experience in sterile pharmaceutical manufacturing and validation is essential, including hands-on experience with equipment qualification, APS and smoke studies.

Skills

Sterile manufacturing

Validation

Regulatory compliance

Education

Degree in Life Sciences, Chemistry, Pharmacy or Engineering

Job description

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

Responsibilities

• 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.

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