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
#J-18808-Ljbffr