Job Type: Contract
Job ID: JO-2208-30529
Consultant: Karen McHugh
Are you a Senior Process Engineer with 5+ years of experience in a process engineering role in the Pharma/Chemical/Biotech industry and understanding and experience e.g. reactors, filter dryers, solvents, powder charging and powder discharging.?
This is a contract role based in Cork.
If you have the relevant experience, send your CV to email@example.com or call Karen on +353 17978720 for a confidential chat.
Senior Process Engineer - Biotech - Ireland
Our Client is one of Ireland's leading EPCm consultancies and a global player in the Semiconductor, Pharma and Biotech sectors.
Our client are the Engineering Service Provider for a Carrigaline, Co. Cork based client.
As the Engineering Service Provider, the on-site team provide full Project Life Cycle support through Concept, Detailed Design, Construction, Commissioning and Validation Activities.
The Senior Process Engineer is a crucial role within the Engineering Service Provider Team to ensure the successful Introduction of New Processes and New Equipment and to perform development and transfer of existing processes across production modules.
Working in a highly regulated and cGMP environment within the pharmaceutical industry the Senior Process Engineer will report 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.
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.
Also includes 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.
uipment specification, process design, commissioning (if required) and as building
Development and Management of the Change Control for the Project using the Client’s Trackwise system.
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 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 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.
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.
Proven track record of process-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.
Minimum 12-month contract
Negotiable hourly rate dependent on experience
Hybrid role with work from home and site visits
Karen McHugh is the consultant managing this position.
If you are a Senior Process Engineer interested in roles based in Dublin you can contact Karen by e-mail at firstname.lastname@example.org or phone +35317978720 for a confidential chat.
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