Process Development Engineer

Takeda Pharmaceutical Co.; Ireland; Presencial; EUR 58 000 - 79 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Process engineering

NPI

Project management

Data analysis

Six Sigma

Communication

English proficiency

Formação académica

Life Sciences or Engineering degree

Ferramentas

Process Analytical Technology (PAT)

BIOVIA Discoverant

SIMCA

Digital twins

Descrição da oferta de emprego

Job Description

At Our Heart

We are committed colleagues who believe in the power of diversity, equity, and inclusion. We offer opportunities based on merit and welcome candidates of all backgrounds. Our team is growing, and we are looking for bright minds who bring creativity, curiosity, and flexibility. What talent do you have?

About the Role

As a Process Development Engineer within our Manufacturing Sciences & Analytical Technology (MSAT) team in Bray, you will provide process engineering expertise and leadership supporting small molecule drug products.

You will play a key role in New Product Introduction (NPI), technical transfers, material qualification, process development and continuous improvement across drug product manufacturing and finished product packaging for our Oral Solid Dosage site.

You will work closely with cross-functional and global teams to introduce new products, materials and technologies, improve existing manufacturing processes, reduce costs and waste, and ensure robust, compliant and efficient manufacturing operations.

How You Will Contribute

• 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.

What You Bring to Taked a

• Degree or Master’s in Life Sciences, Engineering or a related field.
• 3+ years’ experience as a Process Engineer within pharmaceutical manufacturing or another regulated GMP environment.
• Experience with small molecule Oral Solid Dosage (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.
• Experience with Process Analytical Technology (PAT), digital twins, BIOVIA Discoverant or SIMCA is an advantage.
• Strong project/change management, problem-solving and stakeholder management skills.
• Good data, digital and AI capabilities, including statistical and visualisation tools.
• Excellent communication skills and fluency in written and spoken English.

Other Requirements

• Travel: 2-10%.

What Takeda Can Offer You

At Takeda, we are committed to creating better health for people and a brighter future for the world. You will have the opportunity to work in a collaborative environment where innovation, continuous improvement and patient impact are at the heart of what we do.

Locations

Bray, Ireland

Base Salary Range

€57,800.00 - €79,420.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

For information about our benefits, please click here.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time