Project Engineer

1. Job Purpose

Provide engineering support in the development of new equipment and processes, as well as the improvement of existing equipment and processes.

Define, or assist in defining, process and equipment requirements and specifications based on process requirements, applicable safety standards, regulatory requirements, and customer needs.

2. Key Responsibilities

• Perform project management activities for small to medium-scale projects involving new or existing equipment.

• Assist in determining project budgets and resource requirements.

• Evaluate, or assist in evaluating, technologies required to support project and business requirements.

• Develop and present appropriate options and recommendations to management, customers, and key stakeholders.

• Provide technical engineering support throughout projects and equipment/process activities.

• Support and/or develop and execute equipment and process validation activities in accordance with applicable quality systems, procedures, and regulatory requirements.

• Assist with the evaluation, selection, and negotiation of equipment suppliers.

• Utilise appropriate project management tools, including User Requirement Specifications (URS), Microsoft Project, and other relevant tools, to successfully manage projects.

• Develop and maintain the necessary equipment, process, and product knowledge to become a recognised local subject matter expert.

• Measure and evaluate equipment efficiency, downtime, and performance, and assist in developing appropriate maintenance requirements.

• Propose and implement improvement projects that enhance compliance, efficiency, yield, throughput, and overall equipment performance.

• Investigate equipment- and process-related non-conformances, establish root causes, and implement effective corrective and preventive actions using applicable quality-system processes.

• Work collaboratively with cross-functional teams and support day-to-day operational requirements.

• Ensure effective and timely closure of quality-system documentation, including audit actions, non-conformances, CAPAs, and other relevant quality records.

• Ensure appropriate safety and environmental requirements are incorporated into the purchase, installation, modification, and operation of new and existing equipment.

• Promote a culture of continuous improvement, compliance, safety, and operational excellence.

3. Education and Experience

Essential

• Relevant degree or equivalent qualification in Production Engineering, Manufacturing Engineering, Mechanical Engineering, or a related discipline.

Desirable

• 2–4 years' experience in a relevant engineering role.

• Previous experience within a GMP, pharmaceutical, biotechnology, or medical-device manufacturing environment.

• Experience with equipment and process validation activities.

• Experience in process development and optimisation.

• Familiarity with applicable ISO and machinery safety standards.

• Experience applying statistical and problem-solving methodologies, including Lean Six Sigma or equivalent techniques.

• Familiarity with equipment validation within a regulated environment, including experience with FDA requirements, would be advantageous.

• Experience with Statistical Process Control (SPC), process capability analysis, ANOVA, and Design of Experiments (DOE).

• Ability to apply a scientific and structured approach to problem solving, combining analytical and experimental techniques to maximise productivity, quality, and yield.

4. Skills and Attributes

• Ability to develop and maintain strong working relationships across the organisation.

• Ability to motivate, influence, and lead others while working effectively as part of a team.

• Ability to work independently and demonstrate initiative.

• Strong project management, organisational, and communication skills.

• Strong attention to detail and commitment to accuracy.

• Ability to manage multiple priorities and deliver projects within agreed timelines.

• Strong analytical and problem-solving capabilities.

• Practical, hands-on approach to engineering and continuous improvement.

• Commitment to quality, safety, compliance, and operational excellence.