Senior Pharma Validation Engineer - Randburg GMP Compliance

Placements24

Randburg

Hybrid

ZAR 900,000 - 1,200,000

Full time

4 days ago
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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

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.

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