OSD Process Development Engineer — NPI & Transfers

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

Job summary

Takeda Pharmaceutical Co. in Bray, Ireland is seeking a Process Development Engineer for the MSAT team to provide process engineering leadership across small molecule drug product manufacture, transfer, qualification and validation.

You will partner with cross-functional teams to introduce new products, optimise processes, reduce waste, and ensure compliant, robust operations, while delivering risk-based improvements and strong data-driven decisions.

Qualifications

• 3+ years’ experience as a Process Engineer in pharma GMP.
• Experience with small molecule OSD manufacturing and packaging.
• Experience in technical transfers, NPI, process/packaging development, material qualification and validation.
• Strong ability to analyse and interpret manufacturing and packaging data.
• Proven project/change management and stakeholder engagement skills.
• Good data, digital and AI capabilities, including statistical tools.
• Fluent English in written and spoken form.

Responsibilities

• Lead technical transfers, NPI and material qualification projects.
• Manage process development, packaging development, validation and product lifecycle changes.
• Execute feasibility, process optimisation, hold-time and validation studies.
• Provide technical support for complex process issues, deviations and product investigations.
• Identify and implement improvements to increase yield, reduce processing time, defects and waste.
• Analyse manufacturing and process 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 methodologies.
• Collaborate with Production, Packaging, global MSAT teams, vendors and other key stakeholders.
• Ensure compliance with cGMP, quality and safety standards.

Skills

Process engineering

NPI

Project management

Data analysis

Six Sigma

Communication

English proficiency

Education

Life Sciences or Engineering degree

Tools

Process Analytical Technology (PAT)

BIOVIA Discoverant

SIMCA

Digital twins

Job description

Takeda Pharmaceutical Co. in Bray, Ireland is seeking a Process Development Engineer for the MSAT team to provide process engineering leadership across small molecule drug product manufacture, transfer, qualification and validation.

You will partner with cross-functional teams to introduce new products, optimise processes, reduce waste, and ensure compliant, robust operations, while delivering risk-based improvements and strong data-driven decisions.