Role Overview
Delivers technical engineering across capital projects and commercial drug product manufacturing in a sterile GMP biopharmaceutical facility. Hands-on ownership covers project design, P&ID/HAZOP reviews, equipment qualification (CQV), clean utilities, and day-to-day manufacturing support.
Key Responsibilities
- Project Execution & Design: Lead engineering delivery for formulation systems, sterile filtration, PUPSIT, freezing, and visual inspection equipment. Drive P&ID reviews, HAZOP studies, space/utility integration, and single-use assembly concepts.
- CQV & Automation: Coordinate FAT, IOQ, re-validation, and execution tracking. Interface with automation teams on control philosophies and recipe development.
- Clean Utilities & Operations: Provide technical oversight for WFI, clean steam, process air, Nitrogen, and CIP/cleaning systems. Support fill-line operations, tech transfers, CPV monitoring, and decommissioning.
- Quality & Compliance: Lead root-cause deviation investigations and CAPAs. Author SOPs and batch records. Support HPRA/FDA regulatory inspections.
Requirements
- Education: B.Sc. or B.Eng. in Process, Chemical, BioProcess, or Mechanical Engineering.
- Experience: 2–5+ years in process/project engineering within a regulated sterile pharma/biotech environment.
- Technical Skills: Sterile processing (PUPSIT, formulation, filtration), clean utilities (WFI, CIP, clean steam), CQV protocols (IOQ/FAT), P&ID/HAZOP participation, and deviation/CAPA handling.