Aseptic Manufacturing Specialist & Process Innovator

Aphex Group; Dublin; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Aphex Group in Ireland seeks an experienced Specialist Manufacturing to manage aseptic Drug Product processes including fill/lyophilisation and cGMP compliance. You will apply advanced process knowledge, lead change from a manufacturing operations perspective, and drive continuous improvements.

The role involves acting as SME, directing process documentation, and supporting investigations and CAPA implementation to ensure safety, quality, and compliance across assigned manufacturing operations.

Qualifikationen

• Bachelor's degree in Science, Engineering or related discipline with 5+ years' aseptic Drug Product Manufacturing or related cGxP manufacturing experience.
• Experience with regulatory compliance in cGMP manufacturing and knowledge of Eudralex Volume 4, Annex 1.
• Proven ability to work in a high-paced matrix organisation and influence change.
• Excellent decision-making and communication skills for cGxP documentation.

Aufgaben

• Perform as a knowledgeable SME and single point of contact on site for projects and programs.
• Lead process documentation and gatekeeping to maintain structure and control.
• Lead and/or support strategic initiatives to develop future processes.
• Identify and lead continuous improvement projects; ensure timelines and communications.
• Monitor process trends and performance metrics to drive improvements.
• Lead investigations and implement CAPAs to prevent recurrence.

Kenntnisse

Aseptic manufacturing

cGxP compliance

Regulatory knowledge

CAPA investigations

Documentation

Ausbildung

Bachelor's degree in Science, Engineering or related discipline

Jobbeschreibung

Aphex Group in Ireland seeks an experienced Specialist Manufacturing to manage aseptic Drug Product processes including fill/lyophilisation and cGMP compliance. You will apply advanced process knowledge, lead change from a manufacturing operations perspective, and drive continuous improvements.

The role involves acting as SME, directing process documentation, and supporting investigations and CAPA implementation to ensure safety, quality, and compliance across assigned manufacturing operations.