• Contract
  • Cork
  • 1 day ago

Website Asset Recruitment

Asset Recruitment

#339161

Senior Process Engineer

Reports directly to the Programme Manager.

This is a site based role in Carrigaline, Co. Cork.  The role includes but is not limited to; introduction of new processes to existing production modules, troubleshooting issues and upgrading equipment in the production and utility buildings. The successful candidate must have strong leadership and planning qualities, be adaptable to change and be comfortable working cross functional design and production teams delivering to strict deadlines and budgets. Pharmaceutical process knowledge, equipment specification development and understanding of validation is required.

KEY TASKS AND RESPONSIBILITIES

•Leading and Managing the Process Design for Small Molecule API projects for the introduction of new products, equipment, and processes to meet all safety, quality, regulatory and operational requirements.

• Leading the Process Design on non-production projects, such as Utilities, Tanks Farms, Incinerators and Waste Water Treatment plants.

•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).

•Development and Management of the Change Control for the Project using the Client’s Trackwise system.

Other Functional Responsibilities

•Co-ordinating design changes using the Client’s 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 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 record and report any Process changes relating to the projects, which could impact budget and schedule

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

SKILLS, EXPERIENCE AND QUALIFICATIONS

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

•A minimum of 10+ years’ recent relevant experience in a process engineering role in the Pharma/Chemical/Biotech industry.

•Pharmaceutical Manufacturing Process understanding and experience e.g. reactors, filter dryers, solvents, powder charging and powder discharging.

•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.

•Experience with process equipment procurement.

 

Upload your CV/resume or any other relevant file. Max. file size: 40 MB.


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.