QA Validation Engineer Ger TEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services.
We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects.
Role Overview The QA Validation Engineer provides technical quality oversight for the qualification of facilities, equipment, utilities, and manufacturing processes.
You will ensure all startup and ongoing production activities align with GMP, regulatory requirements, and the Site Validation Master Plan.
This is a hands-on individual contributor role requiring autonomy and close collaboration with Engineering, Manufacturing, and QC to ensure compliant project delivery.
Key Responsibilities Technical Oversight: Serve as the QA point of contact for validation strategies, providing technical feedback on New Product Introductions (NPI) and equipment/utility qualification (IQ/OQ/PQ).
Documentation Approval: Perform technical review and approval of validation protocols, reports, and lifecycle documentation to ensure alignment with site and regulatory standards.
QMS Management: Manage assigned Quality Management System activities, including Change Controls, CAPAs, and Deviations related to validation and technical engineering.
Risk Management: Apply Quality Risk Management (QRM) principles and tools (such as FMEA) to assess and mitigate risks within manufacturing processes and equipment design.
Compliance Support: Author and update SOPs; participate in internal and external audits as a Subject Matter Expert (SME) for Validation.
Project Integration: Coordinate with cross-functional teams to ensure validation timelines and documentation support technology transfers and site production schedules.
Qualifications & Experience Education: Bachelor's degree in a Science or Engineering discipline.
Experience: 5+ years in a GMP Quality environment with a focus on providing QA technical support for validation and qualification activities.
Technical Knowledge: Strong understanding of the Project Life Cycle (PLC), c GMP regulations, and industry standards for facility and utility qualification.
Core Competencies Technical Writing: Proficiency in authoring and reviewing complex deviation reports, protocols, and technical SOPs.
Analytical Rigor: Strong problem-solving skills with a focus on data-driven decision-making and risk assessment.
Detail Orientation: Exceptional document review skills and the ability to drive tasks to completion within strict project timelines.
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