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Details

Senior Process Engineer


Reference:SMC 2974 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Process Engineer

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.

Education & Experience
  • 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.

This is an opportunity to contribute to commercial biologics manufacturing within a strategically important facility, with involvement in process science, operational performance and product lifecycle activities.

For further information or a confidential discussion, contact:
Seán McCarthy
[email protected]