Project Engineer

Role Purpose:

• The Projects Process Engineer plays a crucial role within the Project department to ensure the introduction of new equipment and processes and to perform technical development of existing processes.
• Working in a highly regulated and cGMP environment within the pharmaceutical industry the Projects Process Engineer will report directly to the Project Manager on all aspects of the role including but not limited to; introduction of new projects, troubleshooting issues, equipment upgrade and procurement in the manufacturing/packaging and process validation activities.
• This is a projects-based role.

Core Duties and Responsibilities:

• Develops and implements safety policy and strategy for the projects.
• Ensuring that all HSE aspects are considered through all phases of the project, including design, construction, commissioning through to handover to Operations
• Provide practical safety leadership and promoting and improving everybody’s safety culture
• Developing and implementing of project specific plans, safety training and programs
• Leads investigation team on any project related incidents
• Ensure compliance with national legislation.
• Leading and Managing projects for the introduction of new products, equipment and processes to meet all safety, quality, regulatory and operational requirements.
• Process mapping, gap analysis/identification for new and existing pharmaceutical manufacturing processes.
• Process development (as part of technical transfer), troubleshooting and optimisation.
• Project management and co-ordination including planning, scheduling, task management and delegation, milestone planning, communication and reporting.
• Delivering projects on time and on budget.
• Managing and executing process and equipment trials and validation.
• Involved with cross functional teams as part of project planning and deployment including collaboration with supporting departments such as Production/Operations, Quality, Safety, Regulatory Affairs, Facilities and Engineering, Supply Chain and Finance, Project scoping and gap analysis.
• Equipment specification/design/procurement/installation and validation.
• Optimisation of existing processes to achieve product output targets.
• Co-ordinating changes using the approved change control procedure to ensure that cGMP is adhered to.
• Generation, review and approval of project documentation (Scope, User Requirement Specifications etc), trial reports and Standard Operating Procedures.
• Support validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQOQ etc.).
• To provide technical support to system end users of new and existing equipment including but not limited to troubleshooting technical issues and assisting with process investigations.
• To facilitate and participate in meetings and workshops as part of Project and Continuous Improvement activities.
• To develop user materials (e.g. SOPs + training aids) and provide training on new equipment/process functionality. Perform technical review of updates to Standard Operating Procedures (SOPs) related to the equipment/process.

Education & Qualifications Required:

• BEng in Chemical and Processing Engineering or appropriate science or engineering discipline.
• The ability to organise, plan and execute multiple tasks to tight schedules
• Experience with leading cross functional teams is desirable.
• Flexibility and ability to adapt to changing priorities as required.
• Proven track record of project-based activities in the pharmaceutical industry.
• Experience with process technologies.
• Good communication skills combined with an imaginative and creative approach to problem solving.
• Strong leadership skills and the ability to work in cross-functional team environments, as well as independently.

Please note, we do not require agency assistance with this role.