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

About the Role

Our client is seeking a meticulous and experienced Validation Engineer to join their pharmaceutical manufacturing operations in Nelspruit. This role is critical for ensuring that all equipment, processes, and systems used in manufacturing operate consistently and reliably according to predefined specifications and regulatory requirements. You will be responsible for developing, executing, and documenting validation protocols to support compliance with Good Manufacturing Practices (GMP). This position is integral to maintaining the quality and integrity of pharmaceutical products manufactured at the facility, contributing to patient safety and regulatory compliance in Mpumalanga.

Key Responsibilities

• Develop and execute validation master plans (VMPs) and validation protocols for manufacturing equipment, processes, utilities, and computer systems.
• Perform IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), and process validation activities.
• Write detailed validation reports, summarize results, and provide recommendations.
• Ensure all validation activities are conducted in compliance with GMP, FDA, EMA, and other relevant regulatory guidelines.
• Collaborate with engineering, manufacturing, quality assurance, and IT departments to support validation efforts.
• Maintain validation documentation and re-validation schedules to ensure ongoing compliance.
• Participate in regulatory inspections and audits related to validation activities.

Requirements

• Bachelor's degree in Engineering (Mechanical, Electrical, Chemical) or a related scientific field.
• Minimum of 4 years of experience in validation engineering within the pharmaceutical or biotechnology industry.
• Thorough understanding of GMP, validation principles, and regulatory requirements (e.g., FDA 21 CFR Part 11, ICH Q7).
• Experience with various types of pharmaceutical manufacturing equipment and processes.
• Strong technical writing skills and ability to document complex procedures clearly.
• Excellent problem-solving abilities and attention to detail.

Benefits

• Competitive annual salary with performance-based incentives.
• Comprehensive medical insurance, retirement fund, and other employee benefits.
• Paid time off and opportunities for professional development and training.
• Exposure to diverse pharmaceutical manufacturing technologies.
• A stable and growth-oriented work environment in Nelspruit.