Process Scientist

HRM Search Partners; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

HRM Search Partners is seeking a Process Scientist for our Dublin manufacturing facility. You will assess manufacturing events, review data, and translate complex evidence into clear product-impact assessments and recommendations to support process development, manufacturing operations, validation and technology transfer.

The role requires 3–5 years in pharma process development or MSAT, degree in a scientific discipline, and strong writing skills for investigations and validation documents.

Qualifications

• 3–5 years' relevant experience within pharmaceutical or biopharmaceutical process development, MSAT, Technical Operations or manufacturing support.
• Demonstrable hands-on laboratory experience, with practical knowledge of manufacturing processes and how laboratory results translate into commercial operations.
• Strong technical writing capability across product-impact assessments, scientific justifications, investigation reports and validation documentation.
• Knowledge of GMP/GDP, data integrity and electronic quality-management systems such as MasterControl, TrackWise or equivalent.

Responsibilities

• Assess manufacturing events, process excursions, equipment issues and engineering-control failures to determine their potential impact on product quality and the validated state.
• Review QC release, in-process and stability data, including atypical, OOT and OOS results, and provide technical input to investigations and batch-disposition decisions.
• Prepare and critically review product-impact assessments, scientific justifications, investigation reports, validation documents, development reports and other controlled technical records.
• Initiate and progress deviations, change controls and CAPAs, including root-cause analysis, impact assessment, action planning and effectiveness checks.
• Integrate batch, process, equipment, automation, laboratory and validation data into clear, evidence-based technical conclusions.
• Design or review process-development and optimisation studies, including experimental plans, sampling strategies, acceptance criteria and risk assessments.
• Support process scale-up, technology transfer, validation and process performance qualification activities.
• Collaborate with Operations, QA, QC, Engineering, Regulatory, external laboratories and manufacturing partners to deliver technically sound and compliant outcomes.

Skills

Analytical skills

Problem-solving

Stakeholder management

Education

Degree in Chemistry, Biology, Engineering or related scientific discipline

Tools

MasterControl

TrackWise

Job description

Our client is a global pharmaceutical organisation seeking a Process Scientist to join its Dublin manufacturing facility. Reporting to the Senior Manager, Technical Operations, the successful candidate will assess manufacturing, engineering and laboratory issues and translate complex technical evidence into clear, scientifically robust product-impact assessments, conclusions and recommendations. The role will support process development, manufacturing operations, validation, technology transfer and GMP quality-system activities.

Responsibilities

• Assess manufacturing events, process excursions, equipment issues and engineering-control failures to determine their potential impact on product quality and the validated state.
• Review QC release, in-process and stability data, including atypical, OOT and OOS results, and provide technical input to investigations and batch-disposition decisions.
• Prepare and critically review product-impact assessments, scientific justifications, investigation reports, validation documents, development reports and other controlled technical records.
• Initiate and progress deviations, change controls and CAPAs, including root-cause analysis, impact assessment, action planning and effectiveness checks.
• Integrate batch, process, equipment, automation, laboratory and validation data into clear, evidence-based technical conclusions.
• Design or review process-development and optimisation studies, including experimental plans, sampling strategies, acceptance criteria and risk assessments.
• Support process scale-up, technology transfer, validation and process performance qualification activities.
• Collaborate with Operations, QA, QC, Engineering, Regulatory, external laboratories and manufacturing partners to deliver technically sound and compliant outcomes.

Experience

• Three to five years' relevant experience within pharmaceutical or biopharmaceutical process development, MSAT, Technical Operations or manufacturing support.
• Degree in Chemistry, Biology, Engineering or a related scientific discipline.
• Demonstrable hands-on laboratory experience, with practical knowledge of manufacturing processes and how laboratory results translate into commercial operations.
• Experience in process development, process optimisation, scale-up, technology transfer and/or validation.
• Strong technical writing capability across product-impact assessments, scientific justifications, investigation reports, development reports and validation documentation.
• Experience assessing manufacturing events, process deviations or engineering-control issues using process, equipment, validation and batch-history data.
• Knowledge of GMP/GDP, data integrity and electronic quality-management systems such as MasterControl, TrackWise or equivalent.
• Strong analytical, problem-solving and stakeholder-management skills, with the ability to communicate complex scientific conclusions clearly.
• Opportunity to work across process development, manufacturing support and technical operations within a global pharmaceutical organisation.
• Broad exposure to investigations, validation, technology transfer and commercial manufacturing activities.
• Work closely with Operations, Quality, Engineering and Regulatory stakeholders on technically complex product and process issues.
• Opportunity to contribute directly to product-quality decisions, process robustness and continued manufacturing performance.