Process Engineer

Headcount Solutions are seeking to recruit a Process Engineer for one of our multinational client sites in Dublin / Cork.

RESPONSIBILITIES

•Participating in the Process Design for Life Science projects for the introduction of new products, equipment, and processes to meet all safety, quality, regulatory and operational requirements.

•Supporting Process development (as part of technical transfer), troubleshooting and optimisation.

•Development of process estimates, including equipment costs.

•Working with a cross functional Design team to ensure accurate completion of Detailed Design, on time and on budget

•Working with a cross functional team as part of project planning and deployment; including collaboration with supporting departments such as Technical Development, Production/Operations, Quality, Safety, Facilities and Engineering. Process mapping, gap analysis/identification for new and existing pharmaceutical manufacturing processes.

•Equipment specification, process design, commissioning (if required) and as building

•Development and Management of the Change Control for the Project

Other Functional Responsibilities

•Co-ordinating design 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)

•Supervision of Junior Process Engineers if specific project requires additional support

•Support validation activities for project activities including review of validation documentation and attendance at validation activities as required (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.

•To facilitate and participate in meetings and workshops as part of Projects and Continuous Improvement activities.

•Hazop attendance and management of the closeout of the Hazop Recommendations

•Update existing Hazardous Area reports for Equipment/Process

•Provide technical updates to Standard Operating Procedures (SOPs) related to the equipment/process changes

•To perform all activities in accordance with current Good Manufacturing Practice.

•To create, review and approve Site Engineering Specifications and other documents as required, ensuring the acceptability of content and format.

EXPERIENCE AND QUALIFICATIONS

•B.Eng in Chemical and Processing Engineering or appropriate science or engineering discipline.

•A minimum of 8+ years’ recent relevant experience in a process engineering role in the Pharma/Chemical/Biotech industry.

•Secondary Pharmaceutical Manufacturing Process understanding and experience e.g. fill lines.

•A proven track record in process design, development, support and improvement is required.

•A good understanding of ATEX and Hazardous Area Zoning

•The ability to organise, plan and execute multiple tasks to tight schedules

•Flexibility and ability to adapt to changing priorities is required.

•Proven track record of process-based activities in the pharmaceutical industry.

•Experience with process equipment procurement.

•Strong leadership skills and the ability to work in cross-functional team environments, as well as independently.

For immediate consideration please forward your CV