Validation Engineer (Manufacturing Equipment)

About the role

NovintiX is seeking a Validation Engineer to lead the qualification of manufacturing equipment and processes within the medical device sector. The role combines technical expertise in injection moulding equipment, quality assurance, and project management to ensure compliance with industry regulations and company standards.

Key responsibilities

• Plan, design, install and troubleshoot injection moulding and related manufacturing equipment.
• Develop and execute equipment validation protocols (MOC, SAT, IQ, OQ, PQ) for new and upgraded assets.
• Manage change‑control activities and documentation associated with equipment qualification.
• Lead cross‑functional teams on NPI and R&D projects, providing project status reports.
• Apply statistical methods to resolve equipment and process issues.
• Provide training and mentorship to technical staff.
• Support strategic engineering initiatives and maintain quality system documentation.

Required profile

• Strong engineering background with experience in equipment validation within a regulated environment.
• Knowledge of medical device regulations and quality standards.
• Proven ability to manage projects and collaborate across functions.
• Leadership mindset with a focus on continuous improvement.

Required skills

• Injection moulding equipment expertise
• Equipment validation (IQ, OQ, PQ, MOC, SAT)
• Statistical analysis for troubleshooting
• Change management processes