Do you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance! One of our global pharmaceutical clients is looking for Process Engineers to join their team in Dublin for their new large-scale facility.
This is a fantastic opportunity to be part of a fast-paced, €700 million project; with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.
This is a truly exciting project, which when complete will contribute to the manufacturing of a life changing treatment.
Essential Duties and Responsibilities for this process role include, but are not limited to, the following:
- Support the design, construction and qualification of upstream & downstream equipment through to technology transfer and commercialization.
- Support establishment of the commercial process and routine manufacturing by:
- Supporting experimental design, execution, data analysis and interpretation.
- Interpreting trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
- Supporting deviation management.
- Supporting change control prioritization and implementation.
- Authoring and reviewing of batch documentation, technical reports and global regulatory submissions.
- Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.
- Applying LeanSixSigma tools by:
- Securing continuity of an appropriate LSS/CEM level of knowledge.
- Facilitating problem solving & risk assessment (FMEA) projects/meetings.
- Making problems visible and strive for continuous improvement.
- Serving as a key member during internal audits and external inspections/audits
- Lead and support various manufacturing science and technology organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
- Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
- Experience with upstream cell culture and/or downstream purification of biological molecules. Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
- Technical operations experience in the drug substance manufacture of biological molecules at commercial-scale.
- Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
- Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
- Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes
If this sounds of interest then please apply to find out more information!!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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