Process Development Engineer

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

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Project management

Problem solving

Stakeholder management

Data analytics

Statistical tools

Communication (English)

Formação académica

Degree in Life Sciences or Engineering

Ferramentas

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 Takeda

• 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

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.

Work Hour / Type

Worker Type Employee Worker Sub-Type Regular Time Type Full time

Equal Employment Opportunity

Takeda is an equal opportunity employer.

For applicants of U.S and Puerto Rico positions: Click here to learn about our commitment to Equal Employment Opportunity (EEO).