The Process Engineer is a crucial role within the company’s technical department to ensure the introduction of new equipment and processes and to perform technical development of existing processes. The successful candidate will responsible for the introduction of new projects, troubleshooting issues, equipment upgrades and procurement in the manufacturing and process validation activities.
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.
Other Functional Responsibilities
•Optimisation of existing processes to achieve product output targets.
•Co-ordinating changes using the companies 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).
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 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
Clodagh Nerney | Tel: +353 (0) 1 507 9254