Process Project Engineer

Morgan McKinley; Athlone; On-site; EUR 70,000 - 100,000; Full time

Job summary

Morgan McKinley seeks an experienced engineer to lead technical engineering for capital projects in a sterile GMP biopharma facility in Ireland. You will own design reviews, CQV activities, and validation planning across formulation systems and single-use concepts.

You will coordinate with automation teams on control philosophies, support clean utilities, and assist CPV monitoring while driving CAPA investigations and regulatory readiness.

Qualifications

• 2–5+ years in process/project engineering in a regulated sterile pharma/biotech environment.
• Experience delivering capital projects in GMP facilities.
• Knowledge of CQV, P&ID/HAZOP, and deviation/CAPA handling.

Responsibilities

• 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 concepts.
• Coordinate FAT, IOQ, re-validation, and QA interfaces with automation teams.
• Provide technical oversight for clean utilities and support fill-line operations.

Skills

P&ID reviews

HAZOP studies

CQV protocols

Sterile pharma

CAPA handling

Education

B.Sc. or B.Eng. in Process Engineering

B.Sc. or B.Eng. in Chemical Engineering

Tools

FAT/IOQ coordination

Automation interfacing

Job description

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.