Manufacturing Projects Scientist Engineer- NPI
Location: Dublin
About the company:
Innopharma Technical Services, part of Innopharma Group, specializes in the training and provision of highly skilled, project ready, Contract Engineers & Scientists to the (Bio) Pharmaceutical and MedTech Manufacturing Sector.
We are now seeking a Manufacturing Projects Scientist – Engineer to work within the Manufacturing group of our client site based in Co. Dublin.
About the position:
The Manufacturing Support Scientist – Engineer for supporting New Products. He/ She will be key contributor and part of the manufacturing team based in Dublin.
Key responsibilities:
- Lead/support New Product Introduction (NPI), process changes, technology transfers, and manufacturing start-ups.
- Collaborate cross-functionally with Manufacturing, Quality, Engineering, Regulatory, Supply Chain, and Technical teams.
- Support risk assessments, process impact assessments, changeovers, investigations, CAPAs, change controls, and improvement projects.
- Develop and approve GMP manufacturing documentation, including SOPs, batch records, electronic batch records, and PPQ/development documentation.
- Act as a Manufacturing SME, providing technical input, training, knowledge transfer, and operational support.
- Identify and deliver process improvements, promoting Right-First-Time and Lean/OE principles.
- Support audits, product disposition, sustaining operations, and operational safety.
- Support implementation of new manufacturing technologies, including single-use systems.
- Build strong relationships across functions and effectively lead, influence, and communicate with stakeholders.
Preferred Experience:
- Bachelor’s/Master’s degree in Science, Engineering, or related discipline.
- 3–4 years’ experience in upstream/downstream biologics manufacturing and NPI.
- Strong knowledge of GMP biologics manufacturing equipment, processes, and automation.
- Experience writing SOPs and Paper Batch Records; MES/electronic batch record experience advantageous.
- Working knowledge of DeltaV, Syncade MES, and SAP.
- Experience with technical investigations, CAPA, change controls, process improvement, and project management.
- Strong Lean Manufacturing/OE knowledge and problem-solving skills.
- Excellent communication, presentation, organization, leadership, and influencing skills.
- Demonstrated ability to work effectively in cross-functional, changing environments.
Note:
- All applicants must be eligible to work in Ireland with valid visa.
- All applicants must be eligible to work without requiring Visa sponsorship.
If you have any questions, please reach out to: [email protected]
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