We are seeking a Validation Engineer who will design, execute, and govern validation activities for a state-of-the-art medical device manufacturing facility This role focuses on ensuring that high-speed automated equipment, vision systems, and packaging lines are fully compliant, robust, and optimized for regulatory standards.
Responsibilities:
- Design & implement comprehensive validation protocols (IQ/OQ/PQ) for automated packaging and labeling machinery.
- Embed risk-based thinking into equipment onboarding, focusing on the validation of automated components like PLC-driven systems, vision inspection systems, and barcode verifiers.
- Assess, validate, and optimize medical device packaging processes and equipment (e.g., automated pouch sealers, form-fill-seal machines, and printing/labeling systems).
- Define and execute requalification strategies to maintain data integrity, print accuracy, and sterile barrier compliance on the production line.
- Collaborate with Automation, Quality, Manufacturing, and Engineering teams to ensure validation risks are proactively identified, mitigated, and documented.
- Ensure all validation lifecycle documentation (VMP, protocols, reports, and challenge tests) is science-backed, audit-ready, and compliant with regulatory inspections.
Requirements:
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- Minimum of 2 years hands-on validation experience within a regulated medical device manufacturing environment.
- Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and automated system validation standards (e.g., GAMP 5).
- Proven experience or strong exposure to automated packaging validation (e.g., ISO 11607) and labeling verification systems is highly beneficial.
