Process Innovation Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeTechnical Full time €87,654 - €123,456
Job Description

The MS&T Process Engineer plays a pivotal role in providing technical expertise to the Drug Substance Business. Key responsibilities include leading complex investigations, supporting high-impact projects, and ensuring adherence to safety and quality standards.

  • Drive compliance of global policies, procedures, and guidelines by implementing robust processes.
  • Develop, review, and approve qualification documentation to ensure seamless integration with existing systems.
  • Lead experimental design of studies, execution, data analysis, and interpretation to inform business decisions.
  • Identify trends observed in commercial process monitoring and develop strategies for improvement.
  • Support the execution of development and PPQ batches, change control management, and implementation initiatives.
  • Lead multidisciplinary teams for process improvement and troubleshooting activities.
  • Facilitate investigations, ensuring effective Root Cause Analysis and CAPA implementation.
  • Participate in audits and inspections to ensure regulatory compliance.
Required Skills and Qualifications
  • Demonstrated leadership and change management skills with a focus on continuous improvement.
  • Proven track record of delivering high performance through team development and coaching.
  • Evidence of ongoing professional development to stay current with industry trends.
  • Strong collaboration and communication skills to promote knowledge sharing and best practice implementation.

The ideal candidate will possess a relevant technical qualification in Applied Pharmaceutical/Biological/Chemical sciences or an applied Technical/Engineering qualification, with experience leading technical projects and expertise in upstream cell culture and/or downstream purification of biological molecules.

The successful candidate will be able to articulate their understanding of biologics processes, drive decision-making, and impact assessments within a multi-disciplinary team environment.

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