A leading biopharmaceutical company is seeking a Senior Process Engineer to deliver hands-on technical leadership and manufacturing sciences support for clinical and commercial parenteral drug product manufacturing. Based fully on-site in Athlone, you will be the key technical anchor on the floor- driving technology transfers, process performance qualifications (PPQs), real-time troubleshooting, and strategic process optimization.
Key Responsibilities
- Floor Leadership & Execution: Provide real-time, on-site decision-making and rapid issue resolution during active manufacturing campaigns; lead fast-turnaround process impact assessments and CAPAs.
- Tech Transfer & Scale-Up: Support seamless technology transfers from R&D and external partners to commercial manufacturing facilities, assessing facility fit and process robustness.
- Data Analytics & Trending: Conduct real-time campaign data monitoring and multivariate analysis using tools like Tableau, Power BI, Statistica, or SIMCA.
- Cross-Functional Collaboration: Work daily alongside Quality, Engineering, and Manufacturing to refine SOPs, execute batch records, and optimize productivity.
- Regulatory Support: Draft high-quality technical reports and support regulatory filings, audit inspections, and RTQ responses.
Requirements
- Education: Bachelor's degree in Engineering, Biotechnology, or a related scientific discipline.
- Experience: Strong hands-on background in manufacturing sciences, process development, or technical operations for biologics or parenteral/injectable drug products.
- Technical Skills: Proficiency in data visualization and statistical analysis platforms (e.g., Power BI, Tableau, SIMCA, Statistica).
- Soft Skills: Excellent cross-functional communication, analytical problem-solving, and a strong collaborative presence on the shop floor.
Preferred Qualifications
- Experience with regulatory inspections, global health authority audits, and filings.
- Proven track record leading tech transfers and business process optimization projects.
