KPC International – Excellence from Concept to Completion
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.
QUALIFICATION AND VALIDATION ENGINEER
Role Overview
Lead and support Process Performance Qualification (PPQ) activities in line with global standards and regulatory requirements.
KEY RESPONSIBILITIES
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
Education & Experience
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
Skills & Expertise
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.
KPC – International is an Equal Opportunity Employer.
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