GMP Validation Engineer - Pharmaceutical Manufacturing

Placements24; Mbombela (Nelspruit); On-site; ZAR 650,000 - 900,000; Full time

Benefits offered by this job

Performance incentives

Medical insurance

Retirement fund

Paid time off

Development opportunities

Job summary

Placements24 seeks a meticulous Validation Engineer for pharmaceutical manufacturing operations in Nelspruit. You will develop, execute, and document validation protocols to ensure GMP compliance and product quality.

Responsibilities include IQ/OQ/PQ, reports, and maintaining validation documentation. A strong background in GMP and regulatory guidelines is essential, with collaboration across engineering, manufacturing, QA, and IT.

Qualifications

• Bachelor's degree in Engineering or related field.
• Minimum 4 years in validation engineering within pharma/biotech.
• Strong understanding of GMP and regulatory requirements (FDA 21 CFR Part 11, ICH Q7).

Responsibilities

• Develop and execute validation master plans and validation protocols for equipment, processes, utilities, and computer systems.
• Perform IQ, OQ, PQ, and process validation activities.
• Write detailed validation reports, summarize results, and provide recommendations.
• Ensure validation activities comply with GMP, FDA, EMA, and other guidelines.
• Collaborate with engineering, manufacturing, QA, and IT to support validation.
• Maintain validation documentation and re-validation schedules.
• Participate in regulatory inspections and audits related to validation.

Skills

GMP knowledge

Technical writing

Regulatory compliance

Education

Bachelor's degree in Engineering (Mechanical, Electrical, Chemical) or related field

Job description

Placements24 seeks a meticulous Validation Engineer for pharmaceutical manufacturing operations in Nelspruit. You will develop, execute, and document validation protocols to ensure GMP compliance and product quality.

Responsibilities include IQ/OQ/PQ, reports, and maintaining validation documentation. A strong background in GMP and regulatory guidelines is essential, with collaboration across engineering, manufacturing, QA, and IT.