Senior Pharmaceutical Validation Engineer

Placements24; Paarl; On-site; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Medical aid

Retirement fund

Paid time off

Professional development

Job summary

Placements24 is seeking a Senior Pharmaceutical Validation Engineer for on-site work in Paarl. You will develop and execute validation protocols for processes, equipment, cleaning, analytical methods, and computerized systems, ensuring GMP compliance and regulatory readiness.

You will collaborate with engineering, manufacturing, QA, and IT, perform risk assessments, mentor junior staff, and keep validation documentation audit-ready. Strong communication and project management are essential.

Qualifications

• Bachelor's degree in Engineering and relevant discipline.
• 6+ years of validation engineering experience in pharma/biopharma.
• Expertise in process validation, IQ/OQ/PQ, and cleaning validation.
• GMP knowledge and regulatory requirements.
• Ability to write validation protocols and reports.
• Experience with pharmaceutical equipment and processes.
• Strong analytical, problem-solving, and project management skills.
• Excellent communication and teamwork abilities.

Responsibilities

• Develop validation master plans, protocols, and reports for processes, equipment, cleaning, analytical methods, and computerized systems.
• Ensure validation activities comply with GMP, FDA, and other guidelines.
• Collaborate with engineering, manufacturing, QA, and IT to define validation requirements.
• Perform risk assessments to identify critical validation parameters.
• Troubleshoot validation issues and implement corrective actions.
• Maintain validation documentation for audits and inspections.
• Provide technical guidance on validation matters.
• Stay abreast of industry best practices and regulatory changes.
• Train and mentor junior validation engineers and staff.

Skills

Analytical thinking

Project management

Communication skills

Team collaboration

Education

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

Job description

About the Role

Our client, a highly respected pharmaceutical manufacturing entity, is seeking a dedicated Senior Pharmaceutical Validation Engineer to join their operations in Paarl. This on-site role is critical for ensuring that all manufacturing processes, equipment, and facilities meet the stringent quality and regulatory standards required in the pharmaceutical industry. The Senior Validation Engineer will be responsible for developing, executing, and documenting validation protocols for a wide range of systems, including process equipment, cleaning procedures, analytical methods, and computer systems. You will play a key part in maintaining compliance with Good Manufacturing Practices (GMP) and supporting regulatory inspections. This is an essential position for upholding product quality and patient safety.

Key Responsibilities

• Develop and execute validation master plans, protocols, and reports for processes, equipment, cleaning, analytical methods, and computerized systems.
• Ensure all validation activities comply with GMP, FDA, and other relevant regulatory guidelines.
• Collaborate with engineering, manufacturing, quality assurance, and IT departments to define validation requirements.
• Perform risk assessments to identify critical validation parameters and potential areas of concern.
• Troubleshoot validation issues and implement effective corrective actions.
• Maintain validation documentation and ensure it is readily available for audits and inspections.
• Provide technical expertise and guidance on validation-related matters.
• Stay abreast of industry best practices and regulatory changes related to validation.
• Train and mentor junior validation engineers and technical staff.

Requirements

• Bachelor's degree in Engineering (Chemical, Mechanical, Electrical) or a related scientific discipline.
• Minimum of 6 years of experience in validation engineering within the pharmaceutical or biopharmaceutical industry.
• Demonstrated expertise in process validation, equipment qualification (IQ/OQ/PQ), and cleaning validation.
• Strong understanding of GMP and regulatory requirements related to pharmaceutical manufacturing.
• Proficiency in writing clear, concise, and accurate validation protocols and reports.
• Experience with various types of pharmaceutical equipment and manufacturing processes.
• Excellent analytical, problem-solving, and project management skills.
• Strong interpersonal and communication skills, with the ability to work effectively with diverse teams.

Benefits

Our client offers a competitive annual salary and a comprehensive benefits package, including medical aid, retirement fund, and paid time off.

• Medical aid
• Retirement fund
• Paid time off
• Opportunities for advanced training, professional certifications, and attendance at industry seminars.