Process Engineer
- East
- Contract
- CAPEX Projects
With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Process Engineer to join their team to support multiple capital projects taking place onsite in Leinster.
This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Lead/execute production floor-based activities
- Participate on a team of engineers
- Plan and execute C&Q, validation activities as required
- Design & develop engineering studies
- Provide technical input into quality notification by authoring/reviewing/approving investigations
- Execution of equipment/qualification validation programs; including re-qualification and re-validation
- Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
- Statistical data analysis to support development and commercialisation batches
- Support continuous improvement through Lean Six Sigma methodologies
- Leading and active participation in projects, system failure investigations and investigation reports
- Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues
- Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups
- Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other technical discipline
- Prior related work experience; ideally in manufacturing, preferably GMP Setting
- Typically have 5 years related work experience in Aseptic manufacturing / process engineering
- Knowledge of regulatory/core requirements to Irish, European and International Codes, Standards and Practices
- Report, standards, policy writing skills required
- Equipment and process validation
- Sterile filling processes and equipment
- Proficiency in Microsoft Office and job-related computer applications required
- Lean Six Sigma Methodology experience desired
- Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
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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Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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