Role Responsibilities:
- Leading and Managing projects for the introduction of new Oral Solid Dose (OSD) 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, 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.
- Optimisation of existing processes to achieve product output targets.
- Co-ordinating changes using the Client 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, IQ, OQ etc).
- To ensure that all new equipment is bought in accordance with appropriate site procedures & regulations.
- 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.
- 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.
- 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.
- B.Eng in Chemical and Processing Engineering or appropriate science or engineering discipline.
- Relevant experience in a process engineering/projects role in the Pharma/Biotech/Chemical industry.
- Pharmaceutical Manufacturing Process understanding and experience e.g. dry blending, compression, compaction, coating, granulation (wet and dry), containment, material handling etc.
- 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.