Manufacturing Engineer – Validation & Qualification

About the role

NovintiX is seeking a Manufacturing Engineer to lead validation and qualification activities for manufacturing equipment and processes within the medical device sector. The role combines technical engineering expertise, regulatory knowledge, and project leadership to ensure compliance with cGMP, FDA, ISO 13485 and other industry standards.

Key responsibilities

• Plan, execute and manage Installation, Operational and Performance Qualification (IQ/OQ/PQ) protocols for new and existing equipment.
• Maintain compliance with current Good Manufacturing Practices (cGMP) and relevant regulatory standards throughout validation activities.
• Lead root‑cause investigations and implement corrective and preventive actions (CAPA) for equipment issues.
• Develop, review and archive validation protocols, reports and Standard Operating Procedures (SOPs) to ensure audit readiness.
• Support internal audits, regulatory inspections and the preparation of regulatory filings.
• Drive continuous improvement initiatives to optimise equipment performance and reduce waste.
• Provide training and mentorship to junior engineers and technicians on validation practices.

Required profile

• Degree in Engineering or a related scientific discipline.
• Experience in equipment validation, qualification and cGMP environments, preferably within medical device manufacturing.
• Strong understanding of FDA regulations, ISO 13485 and related quality standards.
• Proven ability to manage projects from concept through completion and to work effectively across cross‑functional teams.

Required skills

• IQ/OQ/PQ validation methodology
• Equipment qualification and performance testing
• cGMP compliance
• FDA regulatory requirements
• ISO 13485 standards
• Root cause analysis and CAPA implementation
• SOP development and documentation control
• Audit readiness and regulatory filing support