Summary: Our client, a biopharmaceutical company based in Carlow, is currently seeking a Process Engineer .
The successful candidate will lead activities required to support the Tech Transfer process for New Product Introduction to the site.
This includes, but is not limited to: Tech Transfer, validation programmes and strategies, technical support, process improvement projects, and collaboration within the wider network.
The ideal candidate will work cross-functionally, providing support, coaching, and guidance to project sub-teams.
Responsibilities: • Work collaboratively to promote a safe and compliant culture.
Partner with various stakeholders (e.g.
network groups, third parties, vendors, quality, donor sites, supply chain) to drive excellence in technical transfer programmes.
Serve as the technical engineering representative in internal technical discussions and represent the team at Global Technical Forums as required.
• Adhere to company policies, procedures, and guidelines, as well as regulatory requirements.
Execute current Good Manufacturing Practices (cGMP) in all daily tasks, ensuring all decisions consider GMP and compliance impact.
• Ensure compliance through accurate documentation, timely completion of risk assessments, resolution of corrective actions, and active participation in audits and inspections.
Proactively flag any potential compliance concerns.
• Lead and execute process engineering and validation activities in support of technical transfers.
• Manage and lead multiple technical engineering projects, including process improvements, capital projects, and Lean initiatives.
These may span across multi-disciplinary teams and require global collaboration.
Lead integrated project teams to deliver on project goals and collaborate with cross-functional groups to define scope during the ramp-up to commercial operations.
• Oversee technical deliverables such as validation, quality notifications, change controls, and project support within the technical engineering function.
Apply scientific, product, and process knowledge to develop risk-based approaches to investigations and troubleshooting.
• Promote and embed Lean Six Sigma principles and standard work practices within the technical engineering team (e.g.
structured root cause analysis, statistical process control, data-driven decision making).
• Encourage collaboration between functional teams, continuously seeking process improvements and efficiencies while maintaining compliance.
• Act as a subject matter expert in Equipment Design, C&Q execution and planning, and Process design and validation.
• Liaise with global engineering services, facilities, and specialist vendors to align process requirements and support project delivery.
• Perform additional duties as assigned.
Qualifications & Experience: • Degree or equivalent qualification in Science, Engineering, or a related technical discipline is required.
Green Belt certification is preferred.
• 8+ years' experience in a similar role, ideally at a senior level, with a strong track record in process engineering and/or validation within sterile manufacturing environments (particularly aseptic filling).
Experience leading technical teams through technical transfers, sustaining operations, and organisational change is highly desirable.
• Solid understanding and application of Six Sigma, Lean methodologies, and Quality by Design (QbD) or Continued Process Verification (CPV).
• Comprehensive knowledge of Irish, European, and international regulatory standards, with demonstrated experience executing or managing equipment and process validation in sterile settings, including shipping, filter, and cleaning validation.
• Proficient in automation systems, MES platforms, and Microsoft Office tools, with good working knowledge of job-specific computer applications.
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