Project Engineer – Injection Moulding

About NovintiX

NovintiX is a rapidly expanding engineering and digital transformation firm serving leading clients in Life Sciences, Medical Technology, and Healthcare sectors across the US, Ireland, and Europe. The company focuses on delivering impactful digital initiatives, engineering services, and talent solutions that foster innovation, efficiency, and regulatory compliance.

Role Overview and Responsibilities

• Coordinate and execute the planning, design, installation, and troubleshooting of Injection Moulding and other manufacturing equipment and processes.
• Ensure equipment installations adhere to company specifications, timelines, and budget constraints.
• Develop and carry out validation testing protocols such as Management of Change (MOC), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for qualifying new equipment.
• Manage change control processes related to installation and validation of new equipment and upgrades to existing machinery and processes.
• Contribute leadership and expertise to drive transformational process improvements.
• Collaborate effectively with cross-functional teams to support both routine operations and project goals.
• Perform project management duties, including accurate and timely reporting on project progress.
• Assist in implementing strategic engineering and plant initiatives.
• Provide technical troubleshooting support to resolve equipment, system, and process issues using robust statistical methods.
• Deliver training and develop technical problem-solving skills across various departments.
• Lead or actively engage in cross-functional teams to ensure successful completion of New Product Introduction (NPI) and Research & Development (R&D) projects within schedule.
• Exhibit strong leadership and promote a positive, ethical work culture aligned with Credo and Behavioural Standards within the group.
• Ensure prompt closure of Quality System documentation.
• Work alongside team leaders to formulate and pursue strategic engineering goals and objectives.
• Commit to minimizing environmental impact and ensuring health and safety in all work activities.

Qualifications and Requirements

• Bachelor’s degree in Mechanical Engineering, Polymer Science, or related technical field.
• At least 2 to 4 years of hands-on experience within a validated Medical Device or Pharmaceutical manufacturing environment.
• Demonstrable experience in project management.
• Proficient knowledge in equipment installation and validation processes including SAT, IQ, OQ, and PQ protocols.
• Strong understanding of Injection Moulding technology and mould tooling.
• Experience managing change control for equipment and process modifications.
• Familiarity with procurement and project budget management.
• Ability to prioritize and handle multiple projects concurrently.

Additional Information

All employees must be dedicated to reducing environmental impact and maintaining health and safety standards in their work. The role requires active participation in fostering an ethical and collaborative working culture.