Life Science Recruitment are sourcing a Project Engineer for a global pharmaceutical manufacturer. The ProjectEngineer is a crucial role within our client’s technical 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 ProjectEngineer 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 and process validation activities. This is a projects-based role. The successful candidate must have strong leadership and planning qualities, be adaptable to change and be comfortable leading cross functional teams delivering to strict deadlines. Pharmaceutical process knowledge and equipment procurement and validation experience is required.
Roles & Responsibilities
• 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.
• Leading 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.
Other Functional Responsibilities
• 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 ensure that all new equipment is bought in accordance with the EEM (Early Equipment Management) policy.
• 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.
• Involvement in Continuous Improvement activities including but not limited TPM and six-sigma.
• 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.
Skills & Qualifications
• B.Eng in Chemical and Processing Engineering or appropriate science or engineering discipline.
• A minimum of 3-4 years’ recent experience in a process engineering role in the Pharma/Biotech/Chemical industry.
• Pharmaceutical Manufacturing Process understanding and experience e.g. dry blending, compression, coating, granulation (wet and dry).
• A proven track record in process development, support and improvement is required.
• The ability to organise, plan and execute multiple tasks to tight schedules
• Previous experience in Oral Solid Dose (OSD) manufacturing is preferred.
If you would like further Information you can contact the recruiter directly:
Simon Gillivan | Tel: +353 (0) 1 507 9258