MS&T Bioprocess Specialist

Are you looking for a challenging opportunity in the pharmaceutical industry?

This MS and T Process Engineer position is an excellent chance to utilize your technical skills and experience to drive compliance, safety, and quality within our manufacturing processes.

The ideal candidate will be responsible for leading technical investigations, supporting projects, designing and qualifying equipment, and executing qualification documentation. Additionally, they will interpret trends in commercial process monitoring, support development and PPQ batches, and lead multidisciplinary teams for process improvement and troubleshooting.

• Drive compliance with global policies, procedures, and guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in day-to-day activities.
• Design/Author/Review/Approve/Execute qualification documentation in line with standard processes.
• Lead experimental design of studies, execution, data analysis, and interpretation. Author and review batch documentation, regulatory, and technical documentation.
• Interpret trends observed in commercial process monitoring, proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC), multivariate analyses (MVDA), and further technical investigations and process changes to drive improvements to yield and/or robustness.
• Support the execution of development and PPQ batches, change control management, and implementation.
• Lead multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus through Lean Six Sigma methodologies.

• Demonstrated leadership and change management skills with a continuous improvement focus.
• Proven track record of delivering high performance through development and coaching of a team.
• Evidence of continuous professional development.
• Strong collaboration to promote knowledge sharing and implementation of best practices across the site.
• Motivation to be an inspiring member of a high-performing team and passion to build the future; desire to continuously learn, improve, and develop.
• Demonstrated interpersonal skills including flexibility, collaboration, and inclusion skills and ability to work/upskill/coach a team environment.

• Subject matter expert in upstream/downstream processing and process control strategies. Working knowledge of analytics.
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment.
• Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
• Evidence of continuous professional development. Technical writing skills.
• Ability to effectively articulate understanding of biologics processes to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
• Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) for biologics processes.
• Relevant technical qualification(s) in Applied Pharmaceutical/Biological/Chemical sciences or applied Technical/Engineering qualification.
• Experience leading technical related projects.
• Experience with upstream cell culture and/or downstream purification of biological molecules.
• Experience in preparing for and presenting in front of regulatory audits as SME.
• Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
• Technical operations experience in the drug substance manufacture of biological molecules at commercial-scale.
• Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
• Experience in change management, deviations, and CAPAs management.