Process Engineer III
The Process Engineer III is responsible for supporting and improving manufacturing processes within a regulated production environment, ensuring compliance with quality and safety standards. The role involves leading process development projects, supporting validation activities, and driving continuous improvement across manufacturing operations.
Responsibilities
- Adhere to all site Quality and Safety requirements and actively support related initiatives
- Lead new process development projects while collaborating with cross-functional teams including R&D, commercial, maintenance, and quality
- Support the design and implementation of efficient and scalable manufacturing processes
- Coordinate with suppliers and internal stakeholders to source and install capital equipment required for new processes
- Support process and equipment validation activities in collaboration with the Quality team
- Assist with the development and execution of IQ, OQ, and PQ protocols to ensure regulatory and quality compliance
- Conduct engineering trials to assess process feasibility, optimise operating parameters, and troubleshoot technical issues
- Analyse trial data and recommend process improvements to enhance efficiency, quality, and yield
- Document engineering trial outcomes and provide reports for review and approval
- Travel to customer sites where required to gather design inputs and understand process requirements
- Collaborate with R&D and commercial teams to ensure customer requirements are reflected in process design
- Provide technical expertise during customer interactions related to manufacturing processes
- Drive continuous improvement initiatives focused on process optimisation, waste reduction, and cost savings
- Implement best practices, process controls, and standard operating procedures to improve operational performance
- Manage internal process development projects and coordinate activities with contractors and vendors
- Provide engineering support for existing manufacturing processes while ensuring compliance with safety, quality, and regulatory requirements
- Apply technical knowledge of manufacturing processes to support problem solving, risk mitigation, and process improvements
Requirements
- Bachelor’s degree in Chemical Engineering or a related discipline
- Minimum of five years’ experience in a pharmaceutical, medical device, or related regulated manufacturing environment
- Strong project management capability and experience managing engineering projects
- Ability to work effectively within cross-functional teams and communicate with multiple stakeholders
- Strong time management skills with the ability to manage competing priorities and meet deadlines
- Proficiency in Microsoft Office applications including Outlook, Word, Excel, and PowerPoint
- Experience using statistical tools such as Minitab is advantageous
- Familiarity with AutoCAD or similar design tools is beneficial
- Strong mechanical aptitude with knowledge of process engineering fundamentals
- Understanding of material and energy balances, fluid flow, heat transfer, and mixing processes
- Knowledge of vapour-liquid equilibrium and process scale-up principles
- Experience supporting technology transfer and manufacturing process scale-up
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