Process Project Engineer
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| Job Type | Contractor |
| Area | Kildare, Ireland |
| Sector | Engineering |
| Start Date | |
| Advertiser | Hilda Lynn |
| Telephone | +3539833013 |
| Job Ref | #1002175 |
| Job Views | 298 |
- Description
- Process Project Engineer – Team Horizon
We have an exciting opportunity available for a Process Project Engineer to work on a Pharmaceutical Oral Solid Dose Facility.
The Process Projects Engineer is a crucial role within the Engineering department to ensure the introduction of new equipment and processes and to perform technical development of existing processes.
Working in a highly regulated and cGMP environment within the pharmaceutical industry you will report directly to the Programme Manager on all aspects of the role including but not limited to; introduction of new projects, troubleshooting issues, equipment upgrades and procurement in the manufacturing/packaging and process validation activities.
This is a projects-based role.
What you will be doing:
Leading and Managing projects for the introduction of new Solid Oral Dose 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.
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 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 Project and Continuous Improvement activities.
To approve plant SOPs and other documents as required, ensuring the acceptability of content and format.
To record any deviations relating to the role out of projects, that you are responsible for, through the plant Process Deviation System.
What you need to apply:
B.Eng in Chemical and Processing Engineering or appropriate science or engineering discipline.
A minimum of 5+ years’ recent 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.
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.