The Projects Process Engineer is a crucial role within this pharmaceutical 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 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. 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.
KEY TASKS AND 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 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.
• To approve plant SOPs and other documents as required, ensuring the acceptability of content and format.
• To adhere fully to all safety policies, procedures and regulations issued by Rot.
• To participate in all training and assessment activities related to the role.
• To perform all activities in accordance with current Good Manufacturing Practice.
• To record any deviations relating to the role out of projects, that you are responsible for, through the plant Process Deviation System.
SKILLS, EXPERIENCE AND 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/projects 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
• Experience with leading cross functional teams is desirable.
• Flexibility and ability to adapt to changing priorities is required.
• Proven track record of project based activities in the pharmaceutical industry.
• Experience with process technologies.
• Experience with process equipment procurement.
• 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.
If you would like further Information you can contact the recruiter directly:
Libby Ryan | Tel: +353 (0) 1 507 9254