Biopharma Process Project Engineer (GMP)

Morgan McKinley

Athlone

On-site

EUR 70,000 - 100,000

Full time

4 days ago

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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

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

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