Sterile Process Engineer: CQV & GMP Project Lead

Cpl Group; Roscommon; On-site; EUR 65,000 - 90,000; Full time

Job summary

Cpl Group is seeking an experienced Process/Project Engineer to deliver technical engineering across capital projects and sterile drug product manufacturing in a GMP biopharmaceutical facility.

You will own designs, participate in P&ID/HAZOP reviews, support CQV activities, and oversee clean utilities and day-to-day manufacturing support. The role requires hands-on execution across multiple disciplines and quality/compliance support.

Qualifications

• B.Sc. or B.Eng. in Process, Chemical, BioProcess, or Mechanical Engineering.
• 2–5+ years in process/project engineering within a regulated sterile pharma/biotech environment.
• Experience with CQV protocols (IOQ/FAT) and P&ID/HAZOP participation.
• Experience handling deviations and CAPA investigations.

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 assembly concepts.
• Coordinate FAT, IOQ, re-validation, and execution tracking; interface with automation teams on control philosophies and recipe development.
• Provide technical oversight for WFI, clean steam, CIP, process air, Nitrogen, and CIP/cleaning systems; support fill-line operations and tech transfers.
• Lead root-cause deviation investigations and CAPAs; author SOPs and batch records; support HPRA/FDA regulatory inspections.

Skills

Sterile processing

PUPSIT

Filtration

P&ID/HAZOP

CQV IOQ FAT

Clean utilities

WFI

Deviation handling

CAPA investigations

Education

B.Sc. or B.Eng in Process/ Chemical/ BioProcess/ Mechanical Engineering

Job description

Cpl Group is seeking an experienced Process/Project Engineer to deliver technical engineering across capital projects and sterile drug product manufacturing in a GMP biopharmaceutical facility.

You will own designs, participate in P&ID/HAZOP reviews, support CQV activities, and oversee clean utilities and day-to-day manufacturing support. The role requires hands-on execution across multiple disciplines and quality/compliance support.