Manufacturing Operations Engineer

6 days ago


Dublin, Dublin City, Ireland Pe Global (Uk) Full time

About the Opportunity:

We are seeking a highly skilled Manufacturing Operations Engineer to join our team at Pe Global (UK). The successful candidate will have primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS).

The position is accountable for timely completion of commercial sustaining and technical transfer related milestones, with particular emphasis on new product introduction, Process Validation (PPQ), Continued Process Verification (CPV), Risk Assessment (using QRM tools), and supporting technical and manufacturing deviations.

Key Responsibilities:

  • To provide process expertise in Downstream purification process: buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill.
  • To author and review process technical documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents.
  • To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements.
  • To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.

Requirements:

  • BSc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
  • Experience of authoring CMC sections of regulatory submissions.
  • Minimum 3+ years' experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization.


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