Process Engineer

About NovintiX

NovintiX specializes in engineering services to innovate and transform industries such as Medical Devices, Aerospace, Automotive, Consumer Electronics, and Industrial Equipment. It offers expertise in Product Engineering, Digital Solutions, Supply Chain Management, and Quality Compliance, aiming to support client and employee success while promoting a sustainable, technology-forward future.

Position Overview

The Validation Engineer delivers essential functions ensuring manufacturing equipment, systems, and processes align with regulatory and company standards in the medical device field. This role integrates technical know-how in manufacturing equipment, quality assurance, and project management to lead validation efforts from planning through completion.

Key Duties

• Plan, develop, and guide design, setup, and troubleshooting of Injection Moulding and other manufacturing equipment and processes.
• Ensure equipment complies with company criteria, time schedules, and budget limitations.
• Develop and conduct validation testing phases including MOC, SAT, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment approvals.
• Manage change control activities linked to new installations and upgrades of manufacturing equipment and processes.
• Contribute leadership and insights into process improvements and transformations.
• Collaborate effectively with cross-functional teams to support daily operations and project needs.
• Handle Project Management responsibilities with consistent progress reporting.
• Assist with the rollout of strategic engineering and plant initiatives.
• Troubleshoot issues with equipment and processes using robust statistical methods.
• Provide training to enhance technical problem-solving capabilities within teams.
• Lead or participate in cross-functional collaboration to ensure smooth completion of NPI and R&D projects.
• Maintain a strong leadership presence and promote a positive team work ethic.
• Develop and uphold behavioral standards and company culture within the group.
• Promptly manage closure of Quality System documentation.
• Work with leadership to set and implement strategic engineering objectives.
• Commit to minimizing environmental impact and upholding health and safety standards in all activities.

Qualifications

• Bachelor's degree in Mechanical Engineering, Polymer Science, or a related technical field.
• Between 2 to 4 years of pertinent experience in a medical device or pharmaceutical environment with an emphasis on validation.
• Demonstrated experience managing projects successfully.
• Familiarity with equipment validation methodologies including SAT, IQ, OQ, PQ.
• Experience with Injection Moulding and mould tooling processes.
• Competence in managing change controls correlated to equipment and process adaptations.
• Skills in overseeing procurement activities and managing project financials.
• Capability to juggle multiple projects or assignments concurrently.

Additional Information

Interested candidates are encouraged to submit their resumes via email for consideration.