Senior Pharmaceutical Validation Engineer

Placements24; Randburg; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Competitive salary

Performance incentives

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Career development

Annual leave

Sick leave

Public holidays

Life insurance

Disability coverage

Relocation assistance

Job summary

Placements24 seeks a Senior Pharmaceutical Validation Engineer for their Randburg, Gauteng team. The role ensures that all manufacturing equipment, processes, facilities, and utilities comply with cGMP and regulatory requirements through rigorous validation programs.

You will develop and execute VMPs, IQ/OQ/PQ, and reports, lead validation projects, and collaborate with Engineering, Manufacturing, QA, IT, and external vendors to uphold product quality and patient safety.

Qualifications

• Bachelor's degree in Chemical, Mechanical, or Electrical Engineering.
• 5–7 years in validation engineering within pharma/biotech/medical device.
• Strong knowledge of cGMP and validation principles (FDA 21 CFR Part 11, GAMP 5).
• Experience developing and executing VMPs, IQ/OQ/PQ, and reports.
• Excellent analytical, communication, and project management skills.

Responsibilities

• Develop, review, and execute validation master plans (VMPs), protocols, and reports for equipment, processes, and systems.
• Ensure validation activities comply with cGMP, FDA, EMA, and other guidelines.
• Collaborate with Engineering, Manufacturing, QA, and IT to define validation requirements.
• Perform risk assessments and implement mitigation strategies.
• Investigate deviations and OOS results; recommend corrective actions.
• Maintain validation documentation in an organized, compliant manner.
• Provide technical guidance on validation issues to internal teams and vendors.
• Support regulatory inspections and audits with documentation.
• Stay updated on validation technologies and regulatory expectations.
• Contribute to continuous improvement of validation programs and SOPs.

Skills

Validation engineering

cGMP knowledge

IQ/OQ/PQ protocols

Validation master plans

Risk assessment

Regulatory compliance

Technical reporting

Cross-functional collaboration

Education

Bachelor's degree in Chemical Engineering

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Electrical Engineering

Tools

GAMP 5

Quality Management System

Validation software

Job description

About the Role

Our client, a respected leader in the pharmaceutical manufacturing sector, is seeking a highly experienced Senior Pharmaceutical Validation Engineer to join their esteemed team in Randburg . This vital role ensures that all manufacturing equipment, processes, facilities, and utilities comply with cGMP and other regulatory requirements through rigorous validation protocols. The ideal candidate will possess a strong engineering foundation combined with extensive knowledge of validation principles and pharmaceutical industry best practices. You will be instrumental in developing and executing validation master plans, protocols, and reports, ensuring product quality and patient safety. This is an exceptional opportunity to apply your expertise within the dynamic pharmaceutical landscape of Gauteng , specifically in Randburg . We are looking for a meticulous and proactive individual who can lead validation projects and contribute to a culture of compliance and operational excellence.

Key Responsibilities

• Develop, review, and execute validation master plans (VMPs), protocols (IQ, OQ, PQ), and reports for manufacturing equipment, utility systems, processes, and computer systems.
• Ensure all validation activities are conducted in compliance with cGMP, FDA, EMA, and other relevant regulatory guidelines.
• Collaborate with cross-functional teams (e.g., Engineering, Manufacturing, Quality Assurance, IT) to define validation requirements and strategies.
• Perform risk assessments related to validation activities and implement appropriate mitigation strategies.
• Investigate deviations and out-of-specification (OOS) results during validation studies and recommend corrective actions.
• Maintain all validation documentation and records in an organized and compliant manner.
• Provide technical expertise and guidance on validation-related issues to internal teams and external vendors.
• Support regulatory inspections and audits by providing validation documentation and expertise.
• Stay updated on current validation technologies, methodologies, and regulatory expectations.
• Contribute to the continuous improvement of the validation program and related SOPs.

Requirements

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, or a related discipline.
• Minimum of 5-7 years of experience in validation engineering within the pharmaceutical, biotechnology, or medical device industry.
• Thorough understanding of cGMP regulations and validation principles (e.g., FDA 21 CFR Part 11, GAMP 5).
• Proven experience in developing and executing validation protocols for equipment, processes, facilities, and computer systems.
• Strong knowledge of risk-based approaches to validation.
• Excellent analytical, problem-solving, and decision-making skills.
• Effective written and verbal communication skills, with the ability to prepare clear and concise technical reports.
• Ability to manage multiple projects simultaneously and meet deadlines.
• Proficiency in using standard office software and relevant validation/quality management systems.
• Experience with sterile product manufacturing validation is a significant advantage.

Benefits

• Our client offers a competitive salary, performance incentives, and a comprehensive benefits package, including excellent medical, dental, and vision insurance, and a retirement savings plan.
• We are committed to your career development through access to specialized training, industry conferences, and opportunities for advancement.
• Generous annual leave, paid sick leave, and public holidays are standard.
• Additional benefits include life insurance, disability coverage, and potential relocation assistance for qualified candidates moving to Randburg .