Process Development Engineer is required to provide NPI and process development technical expertise to manufacturing operations by Pharmaceutical client in County Wicklow.
The successful engineer will guide and support the introduction of new products, materials and technologies along with process improvement opportunities and the re-development of legacy processes to increase productivity, reduce manufacturing costs and eliminate quality defects.
You will be part of a diverse team of engineers with exciting career opportunities in a constantly growing industry.
Our client offers an optional hybrid work model for the right candidate.
- Bachelor’s or Master’s Degree (preferred) in a Science or Engineering discipline.
- At least 3 years’ experience as a Process Engineer with Pharmaceutical industry and New Product Introduction (NPI) project experience.
- Experience with operations, process & technical support, projects or validation-based of oral solid dosage manufacturing processes is an advantage.
- Some experience with technical transfers (sending site) for pharmaceutical products an advantage.
- Guide a team during technical transfers (sending site) and new product introduction (NPI) (receiving site) projects following a pre-approved project plan, schedule and current project management best practice.
- Ensure that important manufacturing systems and support structures are in place for major technology transfer and NPI projects and provide technical advice on process engineering requirements.
- Collaborate with technology transfer project counterparts in other client sites.
- Project manage the technical transfers to provide a smooth transition.
- Build early-stage feasibility, technical, process optimisation and process validation studies.
- Suggest and implement sustainable solutions to resolve process issues, reduce processing times, improve yield, reduce defects and eliminate waste.
- Manage the associated Change Records and CAPAs in the tracking system.
- Build process support, process improvement projects and deviation investigations using Six Sigma methodologies.
- Identify cost-effective opportunities for introducing the best manufacturing technologies. Design and introduce these technologies to manufacturing operations.
- Work with local Regulatory Compliance function and Global Regulatory Affairs to support production submissions, Regulatory/Health Authority queries and compliance verifications.
- Produce and review Change Records and Risk Assessments to document and control GxP changes and assess potential process and validation impact.
- Use statistical software packages for data analysis and in the identification and reporting of shifts, signals and trends in process parameters and product quality attributes.
- Provide regular progress updates (written and verbal) on activities within and beyond the Manufacturing Sciences Team as reported in project communication plans or by the relevant partners.
- Follow the compliance matrix of business processes and routine departmental tasks.
- Comply with the relevant industry and Company quality standards and the cGMP about pharmaceutical production.
- Participate in any training plans and promote the corporate values of -ism within the workplace.
- Promote an ethos and culture of safety awareness where safety is accepted as an important part of the business.
- Ensure completion of all SOP reading, training and assessment.
Our client offers great benefits such as Healthcare Cover, Pension Scheme, Bonus, Subsidised canteen, Parking, Health & Wellness programs, Educational Assistance and more.
Please send your CV in confidence to firstname.lastname@example.org