Senior Process Engineering | Biologics Drug Substance
We're currently recruiting for an opportunity with a leading multinational biopharmaceutical manufacturer based in Dublin.

The position is based within an established large-scale biologics drug substance manufacturing facility supporting the production of medicines for global markets.

This opportunity will suit an experienced Process Engineer or MS&T professional with a strong background in upstream cell culture and/or downstream purification, commercial manufacturing support and GMP process improvement.

Responsibilities

• Support upstream and downstream process engineering activities across biologics drug substance manufacturing.
• Provide technical support for commercial manufacturing, process troubleshooting and continuous improvement.
• Support technology transfer, process characterisation, qualification and validation activities.
• Analyse manufacturing process trends using CPV, SPC and statistical data analysis methodologies.
• Investigate process deviations and support the implementation of corrective actions and change controls.
• Support experimental studies focused on improving process yield, performance and robustness.
• Author and review batch documentation, technical reports and regulatory documentation.
• Collaborate with MS&T, manufacturing, quality, analytical and regulatory teams.
• Support risk assessments, FMEA activities and Lean Six Sigma initiatives.
• Contribute to GMP compliance, audit readiness and regulatory inspections.

• Degree in Biological Sciences, Chemical Engineering, Biological Engineering, Chemistry or a related discipline.
• Minimum five years' relevant experience with an MSc or seven years with a BSc, with PhD applicants considered in line with the role requirements.
• Experience in upstream cell culture and/or downstream purification of biologics.
• Strong understanding of commercial GMP drug substance manufacturing.
• Experience supporting process investigations, technical troubleshooting and change controls.
• Knowledge of technology transfer, PPQ, process validation and continued process verification.
• Experience with statistical analysis tools such as JMP or Design Expert would be advantageous.
• Strong technical communication and cross-functional collaboration skills.