Validation Engineer

Placements24; LegKraal Gate; On-site; ZAR 700,000 - 1,000,000; Full time

Benefits offered by this job

Competitive salary & bonuses

Medical aid & retirement benefits

Professional development

Collaborative environment

Job summary

Placements24 in Mahikeng, North West seeks a detail-oriented Validation Engineer to ensure pharmaceutical manufacturing equipment, processes, and facilities meet regulatory standards through validation protocols. You will plan, execute, and document validation activities to guarantee product quality and patient safety.

The role requires a strong technical background in validation principles, cGMP, and regulatory guidelines (FDA/ SAHPRA), plus hands-on experience with IQ, OQ, PQ, and protocol

Qualifications

• Bachelor's degree in Engineering or related field.
• Minimum of 4 years of validation engineering experience in pharma.
• Strong knowledge of validation principles and cGMP requirements.
• Experience with IQ/OQ/PQ and protocol development.

Responsibilities

• Develop and execute validation plans for equipment, processes, cleaning, and analytical methods.
• Perform IQ, OQ, and PQ activities and document results.
• Analyze validation data and address deviations with documented reports.
• Ensure compliance with cGMP and regulatory guidelines (FDA, SAHPRA).
• Collaborate with Engineering, Manufacturing, QA, and other departments to drive validation projects.
• Maintain validation documentation and support regulatory inspections and audits.

Skills

Validation engineering

Regulatory compliance

cGMP

Protocol development

Data analysis

Education

Bachelor's degree in Engineering

Job description

About the Role

Our client is seeking a detail-oriented Validation Engineer to join their team in Mahikeng, North West . This crucial role involves ensuring that all pharmaceutical manufacturing equipment, processes, and facilities meet regulatory compliance standards through rigorous validation protocols. You will be responsible for planning, executing, and documenting validation activities to guarantee the consistent quality and safety of pharmaceutical products. The ideal candidate will possess a strong technical background, a deep understanding of validation principles within the pharmaceutical industry, and a commitment to maintaining the highest standards of quality and compliance.

Key Responsibilities

• Develop and execute validation plans and protocols for equipment, processes, cleaning, and analytical methods.
• Perform qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Analyze validation data, identify deviations, and document results in comprehensive validation reports.
• Ensure all validation activities comply with current Good Manufacturing Practices (cGMP) and relevant regulatory guidelines.
• Collaborate with Engineering, Manufacturing, Quality Assurance, and other departments to ensure successful validation projects.
• Maintain validation documentation and support regulatory inspections and audits.

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 industry .
• In-depth knowledge of validation principles, cGMP, and regulatory requirements (e.g., FDA, SAHPRA).
• Experience with protocol development, execution, and report writing.
• Strong analytical and problem-solving skills, with meticulous attention to detail.
• Ability to work independently and manage multiple validation projects in the North West region.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive medical and retirement benefits.
• Opportunities for professional development and advanced training in validation.
• A challenging and rewarding role contributing to pharmaceutical product quality.
• A collaborative environment within a growing company in Mahikeng .