Process Scientist

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

Job summary

HRM Search Partners is assisting a global pharmaceutical organisation in Dublin to hire a Process Scientist. The role focuses on translating complex manufacturing and laboratory data into robust product-impact assessments and recommendations.

You will support process development, manufacturing operations, validation and technology transfer, while collaborating with QA, QC, Regulatory and external partners to ensure compliant outcomes.

Qualifications

• Degree in Chemistry, Biology, Engineering or related scientific discipline.
• Three to five years’ experience in pharmaceutical/process development or manufacturing support.
• Hands-on laboratory experience with manufacturing relevance.
• Experience in process development, scale-up, tech transfer or validation.
• Strong technical writing across investigations, reports and validation docs.
• Knowledge of GMP/GDP, data integrity and electronic QMS like MasterControl/TrackWise.
• Strong analytical, problem-solving and stakeholder-management skills.

Responsibilities

• Assess manufacturing events, excursions, equipment issues and engineering-control failures for impact on product quality.
• Review QC release, in-process and stability data and support investigations and batch disposition decisions.
• Prepare and review product-impact assessments, investigations and validation documents.
• Initiate deviations, change controls and CAPAs including root-cause analysis.
• Integrate batch, process, equipment and validation data into evidence-based conclusions.
• Design or review process-development and optimisation studies with criteria and risk assessment.
• Support scale-up, technology transfer, validation and PTQ activities.
• Collaborate with Operations, QA, QC, Engineering, Regulatory and external labs to ensure compliant outcomes.

Skills

Process development

Scale-up

Technology transfer

Data integrity

QA collaboration

Technical writing

Education

Chemistry degree

Biology degree

Engineering degree

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.