Process Scientist

Desired Skills: NPI,Process Development,MSAT,lyophilisation

PE Global is currently recruiting for a Process Scientist for a leading multi-national Pharma client based in Dublin.

This is a 12 month contract position.

Role:

• Act as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping.
• Key contributor to product and process investigations, responsible for assessing product and process impact.
• Leads continuous improvement projects to improve process performance and productivity.
• Assess product impact associated with proposed changes to commercial processes under the change control process.
• Generate product impact assessments associated with process excursions and deviations, with reference to product technical documentation.
• Support new product introduction team, as a process subject matter expert; This would include but is not limited to, recipe development and protocol execution, as well as troubleshooting and investigation support.
• Review and approve changes to operating procedures, electronic batch records, and product documentation.
• Identifies and implements operational opportunities for current and new sterile operations.
• Risk assessments and mitigation projects relating to line performance.
• Perform process gap analysis and developing strategies to close gaps.
• Data trend analysis for all performance aspects of the area.
• Troubleshooting performance trends.

Requirements:

• Typically 4-6 years drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling or lyophilisation
• Qualification in Lean and 6-sigma methodologies would be an advantage.
• New product introduction (NPI), process development, MSAT experience in a GMP environment would be advantageous.

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV to niamh.mcdonald@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***