Qualification and Validation Engineer

KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.

We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life-changing products to patients.

Lead and support Process Performance Qualification (PPQ) activities in line with global standards and regulatory requirements.

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• Develop and execute PPQ strategies (batch sizing, sampling, acceptance criteria, statistical methods)
  
• Author and review PPQ protocols, reports, and validation documentation
  
• Contribute to the Process Validation Master Plan (PVMP)
  
• Support lifecycle changes including tech transfers and post-approval updates
  
• Perform risk assessments and apply risk-based validation approaches
  
• Ensure timely closure of deviations and CAPAs
  
• Maintain audit-ready documentation across the validation lifecycle
  
• Collaborate cross-functionally (MSAT, Manufacturing, QC, QA)
  
• Support inspections and audits with technical expertise
  
• Deliver training and guidance on PPQ activities
  
• Design and implement Continued Process Verification (CPV) programs
  

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• Degree in Science or Engineering
  
• 3–5 years’ experience in GMP-regulated pharma manufacturing, validation, or QA
  
• Hands-on PPQ experience (design, execution, reporting)
  
• Strong background in validation documentation and quality systems
  

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• Strong knowledge of process validation lifecycle and cGMP (FDA, EU, ICH)
  
• Experience with statistical methods for validation
  
• Familiarity with equipment and systems qualification
  
• Proven experience in deviations, CAPA, and change control
  
• Strong project management and communication skills
  
• Collaborative, adaptable, and solution-focused mindset
  

KPC -International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others. xcfaprz

KPC – International is an Equal Opportunity Employer.