Pharma Process Development Engineer – NPI & Tech Transfer

Takeda Pharmaceutical Co.; Bray; On-site; EUR 58,000 - 79,000; Full time

Job summary

Takeda in Bray, Ireland, is seeking a Process Development Engineer to join the Manufacturing Sciences & Analytical Technology (MSAT) team. You will support small molecule drug product manufacturing and packaging, lead NPI, technical transfers and material qualification.

You will drive process development and continuous improvement, collaborate with cross-functional and global teams, manage Change Records, CAPAs and risk assessments, and ensure cGMP compliance and safety across operations.

Qualifications

• Degree or Master’s in Life Sciences, Engineering or a related field.
• 3+ years’ experience as a Process Engineer in pharma GMP environments.
• Experience with small molecule OSD manufacturing and packaging.
• Experience in transfers, NPI, process/packaging development, material qualification and validation.
• Fluent English written and spoken.

Responsibilities

• Lead technical transfers, NPI and material qualification projects.
• Manage process development, packaging development, validation and lifecycle changes.
• Execute feasibility, process optimisation, hold-time and validation studies.
• Provide technical support for complex process issues, deviations and investigations.
• Identify improvements to increase yield, reduce processing time, defects and waste.
• Analyse manufacturing data to identify trends and support continued process verification.
• Manage Change Records, CAPAs and Risk Assessments within the QMS.
• Prepare technical and regulatory documentation and support Health Authority inspections.
• Support process improvement and deviation investigations using Six Sigma.
• Collaborate with Production, Packaging, global MSAT teams, vendors and other key stakeholders.
• Ensure compliance with cGMP, quality and safety standards.

Skills

Project management

Problem solving

Stakeholder management

Data analytics

Statistical tools

Communication (English)

Education

Degree in Life Sciences or Engineering

Tools

PAT

BIOVIA Discoverant

SIMCA

Digital twins

Job description

Takeda in Bray, Ireland, is seeking a Process Development Engineer to join the Manufacturing Sciences & Analytical Technology (MSAT) team. You will support small molecule drug product manufacturing and packaging, lead NPI, technical transfers and material qualification.

You will drive process development and continuous improvement, collaborate with cross-functional and global teams, manage Change Records, CAPAs and risk assessments, and ensure cGMP compliance and safety across operations.